Not provided
Not provided
Not provided
Not provided
Strategic re-prioritization by the IMP supplier. Decision not safety-related
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
This is an open-label, single-armed, prospective single-centre clinical study to evaluate the effect of riociguat on right heart size and function in patients with manifest PAH and CTEPH.
Right heart size and function are of utmost prognostic importance in PAH/CTEPH. RV performance measured by echocardiography and enlarged RA area have been shown to be independent prognostic factors in PAH. Recently, a retrospective single centre study has shown that riociguat treatment was associated with a significant reduction of RV and RA area after 3, 6 and 12 months compared to baseline. RA area significantly decreased after 12 months and RV systolic function assessed with tricuspid annular plane systolic excursion (TAPSE) improved after 6 and 12 months of riociguat therapy. The results were confirmed by a recent retrospective multicentre study. It is therefore reasonable to assume a beneficial effect of riociguat on right heart size and function.
The primary efficacy endpoint in this study is the change in RV and RA area from baseline to 24 weeks. Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability. Patients who discontinue medication prematurely will be asked to continue with study assessments and perform study visits as outlined in the protocol.
Medical examinations comprise medical history, physical examination, electrocardiogram (ECG), blood gas analyses, lung function tests, laboratory testing (including NT-proBNP), echocardiography at rest, and right heart catheterization (RHC) according to clinical practice of the PH centre.
The prospective period of data collection comprises a 24-week study period a follow-up phase of about 30±7 days.
Outcome (survival and transplant-free survival) of all patients will be assessed when the last patient has terminated his/her 24-week observation period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat | Other | Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study. Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks. Study medication will be provided orally with or without food. Tablets should be taken three times daily approximately 6 to 8 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat | Drug | Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability. During the titration phase, each patient will be asked to measure their peripheral systolic blood pressure and the heart rate at home three times per day and document the values in the patient diary. The results will be examined by the investigator during each visit/phone call-visit. Provided that the systolic blood pressure is ≥ 95 mmHg measured at trough before intake of each dose and the patient has no signs or symptoms of hypotension, the dose of study medication will be titrated by +0.5 mg tid every 2 weeks until maximal tolerated dosage (maximal permitted dose: of 2.5 mg tid). After the titration period, blood pressure should be measured upon signs or symptoms of hypotension. Maintenance dose: The established individual dose should be maintained unless signs and symptoms of hypotension occur. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in RV (Right Ventricular) Area | echocardiographic analysis right ventricular (RV) area, measured by echocardiography. | Baseline to 24 weeks |
| Change in RA (Right Atrial) Area | echocardiographic analysis | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in RV (Right Ventricular) Area | echocardiographic analysis | baseline to 12 weeks |
| Change in RA (Right Atrial) Area | echocardiographic analysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women, or breast-feeding women, or women of childbearing potential not able or willing to comply with study-mandated contraception methods specified above.
Patients with PH specific treatment <2 months before screening.
Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
Patients with underlying medical disorders with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumour mass).
Patients with a history of severe or multiple drug allergies
Patients with hypersensitivity to the investigational drug or any of the excipients.
Patients unable to perform a valid 6MWD test (e.g. orthopaedic disease, peripheral artery occlusive disease, which affects the patient´s ability to walk).
The following specific medications for concomitant treatment of PH or medications which may exert a pharmacodynamic interaction with the study drug are not allowed:
Pulmonary diseases exclusions
Cardiovascular exclusions:
Exclusions related to disorders in organ function:
a) Clinically relevant hepatic dysfunction indicated by: i. bilirubin >2 times upper limit normal ii. and / or hepatic transaminases >3 times upper limit normal iii. and / or signs of severe hepatic insufficiency (e.g. impaired albumin synthesis with an albumin < 32 g/l, hepatic encephalopathy > grade 1a: West Haven Criteria of Altered Mental Status In Hepatic Encephalopathy) b) Renal insufficiency (glomerular filtration rate <30 ml/min e.g. calculated based on the Cockcroft formula).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ekkehard HD Grünig, MD | Thoraxklinik at the University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital | Heidelberg | 69126 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11923049 | Background | Raymond RJ, Hinderliter AL, Willis PW, Ralph D, Caldwell EJ, Williams W, Ettinger NA, Hill NS, Summer WR, de Boisblanc B, Schwartz T, Koch G, Clayton LM, Jobsis MM, Crow JW, Long W. Echocardiographic predictors of adverse outcomes in primary pulmonary hypertension. J Am Coll Cardiol. 2002 Apr 3;39(7):1214-9. doi: 10.1016/s0735-1097(02)01744-8. | |
| 23140849 |
Not provided
Not provided
Overall, 30 patients were enrolled and commenced study treatment.
Participants were recruited between April 2022 and May 2025. The first participant was enrolled on 13 April 2022, the last on 30 May 2025.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Riociguat | Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study. Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks. Study medication will be provided orally with or without food. Tablets should be taken three times daily approximately 6 to 8 hours apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics are reported for all randomized participants, consitent with the intention-to-treat population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Riociguat Group | Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in RV (Right Ventricular) Area | echocardiographic analysis right ventricular (RV) area, measured by echocardiography. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | cm^2 | Baseline to 24 weeks |
|
Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Riociguat | Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study. Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks. Study medication will be provided orally with or without food. Tablets should be taken three times daily approximately 6 to 8 hours apart. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fluid overload | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitation | Cardiac disorders | MedDRA | Non-systematic Assessment |
Inherent limitations of single-center, open-label studies with limited sample size and no control group. Early study cessation (not safety-related) reduced treatment exposure in several patients, potentially affecting effect size. RVOT VTI (Right Ventricular Outflow Tract Velocity-Time Integral) and CPET (Cardiopulmonary Exercise Testing) values are not reported due to data gaps. RVOT VTI was not collected due to technical issues; CPET was not feasible in most cases due to COVID-19 restrictions
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Ekkehard Grünig | Thoraxklinik Heidelberg gGmbH | +49 6221 396 | 1230 | PH-Studies.THOR@med.uni-heidelberg.de |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 28, 2022 | Feb 13, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2025 | Oct 28, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| baseline to 12 weeks |
| Change in Systolic Pulmonary Artery Pressure (sPAP) | echocardiographic analysis | baseline to 12 weeks |
| Change in Systolic Pulmonary Artery Pressure (sPAP) | echocardiographic analysis | baseline to 24 weeks |
| Change in RV Fractional Area Change (FAC) | echocardiographic analysis | baseline to 24 weeks |
| Change in RV Fractional Area Change (FAC) | echocardiographic analysis | baseline to 12 weeks |
| Change in Peak Velocity of Tricuspid Regurgitation (TRV) | echocardiographic analysis | baseline to 12 weeks |
| Change in Peak Velocity of Tricuspid Regurgitation (TRV) | echocardiographic analysis | baseline to 24 weeks |
| Change in Inferior Vena Cava (IVC) Diameter | echocardiographic analysis | baseline to 24 weeks |
| Change in Inferior Vena Cava (IVC) Diameter | echocardiographic analysis | baseline to 12 weeks |
| Change in Right Ventricle Outflow Tract Velocity Time Integral (RVOT VTI) | echocardiographic analysis | baseline to 12 weeks |
| Change in Eccentricity Index (EI) | Change in left ventricular eccentricity index (LV-EI) from baseline at 24 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perpendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload | baseline to 24 weeks |
| Change in Eccentricity Index (EI) | Change in left ventricular eccentricity index (LV-EI) from baseline at 12 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perpendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload | baseline to 12 weeks |
| Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) | echocardiographic analysis | baseline to 12 weeks |
| Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) | echocardiographic analysis | baseline to 24 weeks |
| Change in Right Ventricular Pump Function (Qualitative) | echocardiographic analysis | baseline to 24 weeks |
| Change in Left Ventricular Pump Function (Qualitative) | echocardiographic analysis | baseline to 24 weeks |
| Change in Right Ventricular Pump Function (Qualitative) | echocardiographic analysis | baseline to 12 weeks |
| Change in Left Ventricular Pump Function (Qualitative) | echocardiographic analysis | baseline to 12 weeks |
| Change in Left Atrial (LA) Diameter | echocardiographic analysis | baseline to 12 weeks |
| Change in Left Atrial (LA) Diameter | echocardiographic analysis | baseline to 24 weeks |
| Change in Left Ventricular (LV) Diastolic Function | echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time) | baseline to 12 weeks |
| Change in Diameters of Pulmonary Artery (PA) | echocardiographic Analysis | baseline to 12 weeks |
| Change in Diameters of Pulmonary Artery (PA) | echocardiographic Analysis | baseline to 24 weeks |
| Change in Cardiac Index (CI) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Cardiac Output (CO) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Systolic Pulmonary Arterial Pressure (sPAP) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Diastolic Pulmonary Arterial Pressure (dPAP) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Mean Pulmonary Arterial Pressure (mPAP) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Pulmonary Arterial Wedge Pressure (PAWP) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Right Atrial Pressure (RAP) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Pulmonary Vascular Resistance (PVR) | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in Central Venous Saturation From Pulmonary Artery | Pulmonary hemodynamics by right heart catheterization | baseline and after 24 weeks |
| Change in 6-minute Walking Distance | Change in exercise capacity | baseline to 12 weeks |
| Change in 6-minute Walking Distance | Change in exercise capacity | baseline to 24 weeks |
| Forced Vital Capacity (FVC) | Change in Lung function Tests | baseline to 12 weeks |
| Forced Vital Capacity (FVC) | Change in Lung function Tests | baseline to 24 weeks |
| Change in Forced Expiratory Volume in One Second (FEV1) | Change in Lung function Tests | baseline to 12 weeks |
| Change in Forced Expiratory Volume in One Second (FEV1) | Change in Lung function Tests | baseline to 24 weeks |
| Change in FEV1% of Maximal Vital Capacity (VC Max) | Change in Lung function Tests | baseline to 12 weeks |
| Change in FEV1% of Maximal Vital Capacity (VC Max) | Change in Lung function Tests | baseline to 24 weeks |
| Change in Total Lung Capacity (TLC) | Change in Lung function Tests | baseline to 12 weeks |
| Change in Total Lung Capacity (TLC) | Change in Lung function Tests | baseline to 24 weeks |
| Change in Residual Volume (RV) | Change in Lung function Tests | baseline to 12 weeks |
| Change in Residual Volume (RV) | Change in Lung function Tests | baseline to 24 weeks |
| Change in Diffusion-limited Carbon Monoxide (DLCO) | Change in Lung function Tests | baseline to 24 weeks |
| Change in Diffusion-limited Carbon Monoxide (DLCO) | Change in Lung function Tests | baseline to 12 weeks |
| Change in DLCO/VA (Krogh) Factor | Change in Lung function Tests | baseline to 12 weeks |
| Change in DLCO/VA (Krogh) Factor | Change in Lung function Tests | baseline to 24 weeks |
| Change in Partial Pressure of Oxygen (pO2) | Change in capillary or arterial blood gas analysis | baseline to 12 weeks |
| Change in Partial Pressure of Oxygen (pO2) | Change in capillary or arterial blood gas analysis | baseline to 24 weeks |
| Change in Partial Pressure of Carbon Dioxide (pCO2) | Change in capillary or arterial blood gas analysis | baseline to 12 weeks |
| Change in Partial Pressure of Carbon Dioxide (pCO2) | Change in capillary or arterial blood gas analysis | baseline to 24 weeks |
| Change in Oxygen Saturation (SaO2) | Change in capillary or arterial blood gas analysis | baseline to 12 weeks |
| Change in Oxygen Saturation (SaO2) | Change in capillary or arterial blood gas analysis | baseline to 24 weeks |
| Change in pH | Change in capillary or arterial blood gas analysis | baseline to 24 weeks |
| Change in pH | Change in capillary or arterial blood gas analysis | baseline to 12 weeks |
| Change in Blood Pressure | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Blood Pressure | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Heart Rate | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Heart Rate | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Workload | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Workload | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Oxygen Consumption as Total (VO2) | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Oxygen Consumption as Total (VO2) | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Exhaled Carbon Dioxide (VCO2) | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Exhaled Carbon Dioxide (VCO2) | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Oxygen Saturation (SpO2) | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Oxygen Saturation (SpO2) | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Oxygen Pulse | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Oxygen Pulse | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Minute Ventilation (VE) | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Minute Ventilation (VE) | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| Change in Respiratory Equivalents for Oxygen at Rest | Change in Cardiopulmonary exercise testing: The respiratory equivalent for oxygen represents the ratio of minute ventilation (VE) to oxygen uptake (VO₂) and reflects the efficiency of ventilation relative to oxygen consumption. | baseline to 12 weeks |
| Change in Respiratory Equivalents for Oxygen at Rest | Change in Cardiopulmonary exercise testing: The respiratory equivalent for oxygen represents the ratio of minute ventilation (VE) to oxygen uptake (VO₂) and reflects the efficiency of ventilation relative to oxygen consumption. | baseline to 24 weeks |
| Change in Respiratory Equivalents for Carbon Dioxide | Change in Cardiopulmonary exercise testing: The respiratory equivalent for carbon dioxide represents the ratio of minute ventilation (VE) to carbon dioxide production (VCO₂) and reflects ventilatory efficiency with respect to carbon dioxide elimination. | baseline to 12 weeks |
| Change in Respiratory Equivalents for Carbon Dioxide | Change in Cardiopulmonary exercise testing: The respiratory equivalent for carbon dioxide represents the ratio of minute ventilation (VE) to carbon dioxide production (VCO₂) and reflects ventilatory efficiency with respect to carbon dioxide elimination. | baseline to 24 weeks |
| Change in Respiratory Reserve | Change in Cardiopulmonary exercise testing | baseline to 12 weeks |
| Change in Respiratory Reserve | Change in Cardiopulmonary exercise testing | baseline to 24 weeks |
| WHO FC | Change in WHO functional class | baseline to 12 weeks |
| WHO FC | Change in WHO functional class | baseline to 24 weeks |
| NT-proBNP | Change in laboratory parameters | baseline to 12 weeks |
| NT-proBNP | Change in laboratory parameters | baseline to 24 weeks |
| Haemoglobin Changes | Change in laboratory parameters | baseline to 12 weeks |
| Haemoglobin Changes | Change in laboratory parameters | baseline to 24 weeks |
| Haematocrit Changes | Change in laboratory parameters | baseline to 12 weeks |
| Haematocrit Changes | Change in laboratory parameters | baseline to 24 weeks |
| SGOT/AST Changes | Change in liver enzymes | baseline to 12 weeks |
| SGOT/AST Changes | Change in liver enzymes | baseline to 24 weeks |
| SGPT/ALT Changes | Change in liver enzymes | baseline to 12 weeks |
| SGPT/ALT Changes | Change in liver enzymes | baseline to 24 weeks |
| Bilirubin Changes | Change in liver enzymes | baseline to 12 weeks |
| Bilirubin Changes | Change in liver enzymes | baseline to 24 weeks |
| CRP Changes | Change in laboratory parameters | baseline to 12 weeks |
| CRP Changes | Change in laboratory parameters | baseline to 24 weeks |
| Sodium Changes | Change in laboratory parameters | baseline to 12 weeks |
| Sodium Changes | Change in laboratory parameters | baseline to 24 weeks |
| Urea Changes | Change in renal parameters | baseline to 12 weeks |
| Urea Changes | Change in renal parameters | baseline to 24 weeks |
| Creatinine Changes | Change in renal parameters | baseline to 12 weeks |
| Creatinine Clearance Changes | Change in renal parameters | baseline to 12 weeks |
| Creatinine Changes | Change in renal parameters | baseline to 24 weeks |
| Creatinine Clearance Changes | Change in renal parameters | baseline to 24 weeks |
| Change in IVC Collapse | echocardiographic analysis | baseline to 12 weeks |
| Change in IVC Collapse | echocardiographic analysis | baseline to 24 weeks |
| SF-36: Physical Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Physical Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Pain | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: General Health Perception | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Vitality | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Social Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Emotional Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Mental Well-being | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Physical Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Mental Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 24 weeks |
| SF-36: Physical Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Physical Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Pain | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: General Health Perception | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Vitality | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Social Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Emotional Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Mental Well-being | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Physical Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| SF-36: Mental Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | baseline to 12 weeks |
| Change in Oxygen Consumption Per kg Body Weight (VO2/kg) | Change in Cardiopulmonary Exercise testing | Baseline to 24 weeks |
| Change in Oxygen Consumption Per kg Body Weight (VO2/kg) | Change in cardiopulmonary exercise testing | Baseline to 12weeks |
| Change in Right Ventricle Outflow Tract Velocity Time Integral (RVOT VTI) | echocardiographic analysis | baseline to 24 weeks |
| Bossone E, D'Andrea A, D'Alto M, Citro R, Argiento P, Ferrara F, Cittadini A, Rubenfire M, Naeije R. Echocardiography in pulmonary arterial hypertension: from diagnosis to prognosis. J Am Soc Echocardiogr. 2013 Jan;26(1):1-14. doi: 10.1016/j.echo.2012.10.009. Epub 2012 Nov 8. |
| 25211049 | Background | Austin C, Alassas K, Burger C, Safford R, Pagan R, Duello K, Kumar P, Zeiger T, Shapiro B. Echocardiographic assessment of estimated right atrial pressure and size predicts mortality in pulmonary arterial hypertension. Chest. 2015 Jan;147(1):198-208. doi: 10.1378/chest.13-3035. |
| 26011408 | Background | Marra AM, Egenlauf B, Ehlken N, Fischer C, Eichstaedt C, Nagel C, Bossone E, Cittadini A, Halank M, Gall H, Olsson KM, Lange TJ, Grunig E. Change of right heart size and function by long-term therapy with riociguat in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2015 Sep 15;195:19-26. doi: 10.1016/j.ijcard.2015.05.105. Epub 2015 May 19. |
| 30567595 | Background | Marra AM, Halank M, Benjamin N, Bossone E, Cittadini A, Eichstaedt CA, Egenlauf B, Harutyunova S, Fischer C, Gall H, Ghofrani HA, Hoeper MM, Lange TJ, Olsson KM, Klose H, Grunig E. Right ventricular size and function under riociguat in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (the RIVER study). Respir Res. 2018 Dec 19;19(1):258. doi: 10.1186/s12931-018-0957-y. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Values for weight are missing for one participant. | Mean | Standard Deviation | kg |
|
| Duration of Pulmonary hypertension (PH) | Mean | Standard Deviation | years |
|
| Vital signs: Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Vital signs: Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Vital signs: Heart rate | Mean | Standard Deviation | beats/min |
|
| Vital signs: Oxygen saturation (SpO2) | Values for SpO2 are missing for one participant. | Mean | Standard Deviation | percent |
|
| WHO Functional Class | WHO Classification from I (symptom free) to IV (symptoms at rest) | Count of Participants | Participants | No |
|
| PAH Etiology | Count of Participants | Participants |
|
| Concomitant diseases | Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number. | Count of Participants | Participants |
|
| Blood gas analysis: Oxygen saturation (SaO2) | Values for blood gas analysis are missing for four participants. | Mean | Standard Deviation | percent |
|
| Blood gas analysis: Partial pressure of oxygen (PaO2) | Values for blood gas analysis are missing for one participant. | Mean | Standard Deviation | mmHg |
|
| Blood gas analysis: Partial pressure of carbon dioxide (PaCO2) | Values for blood gas analysis are missing for one participant. | Mean | Standard Deviation | mmHg |
|
| Blood gas analysis: pH | Values for blood gas analysis are missing for one participant. | Mean | Standard Deviation | pH |
|
| Blood gas analysis: Bicarbonates | Values for bicarbonates are missing for two participants. | Mean | Standard Deviation | mmol/l |
|
| Blood gas analysis: Base excess | Values for base excess are missing for two participants. | Mean | Standard Deviation | mmol/l |
|
| Hemodynamics at rest: Right atrial pressure (RAP) | Mean | Standard Deviation | mmHg |
|
| Hemodynamics at rest: systolic pulmonary arterial pressure (sPAP) | Mean | Standard Deviation | mmHg |
|
| Hemodynamics at rest: diastolic pulmonary arterial pressure (dPAP) | Mean | Standard Deviation | mmHg |
|
| Hemodynamics at rest: mean pulmonary arterial pressure (mPAP) | Mean | Standard Deviation | mmHg |
|
| Hemodynamics at rest: Pulmonary arterial wedge pressure (PAWP) | Mean | Standard Deviation | mmHg |
|
| Hemodynamics at rest: Cardiac output (CO) | Mean | Standard Deviation | l/min |
|
| Hemodynamics at rest: Cardiac index (CI) | Mean | Standard Deviation | l/min/m^2 |
|
| Hemodynamics at rest: Pulmonary vascular resistance (PVR) | Mean | Standard Deviation | WU |
|
| Hemodynamics at rest: Venous oxygen saturation (SvO2) | Mean | Standard Deviation | percent |
|
| 6 Minute walking distance: Distance | Mean | Standard Deviation | m |
|
| 6 Minute walking distance: Oxygen saturation at test end | Mean | Standard Deviation | percent |
|
| 6 Minute walking distance: Borg dyspnea score | Measure Description: The Borg Scale (Breathlessness Scale) is commonly used to measure shortness of breath of patients or in sports medicine. In this study, the Borg Scale was applied to record dyspnea immediately following the 6-minute walk test. The Borg Scale according to the ATS guidelines (ATS 2002) ranges from 0 (no dyspnea at all) to 10 (maximal dyspnea) | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Physical functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Physical role functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Pain | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: General health perception | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Vitality | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Social functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Emotional role function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Mental well-being | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Physical summation score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Short Form-36 Heath Survey: Mental summation score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calcu | Values for Short Form-36 survey are missing for one participant. | Mean | Standard Deviation | scores on a scale |
|
| Echocardiography at rest: estimated systolic pulmonary arterial pressure (sPAP) | Mean | Standard Deviation | mmHg |
|
| Echocardiography at rest: Right atrial (RA) area | Mean | Standard Deviation | cm^2 |
|
| Echocardiography at rest: Right ventricular (RV) area | Mean | Standard Deviation | cm^2 |
|
| Echocardiography at rest: Tricuspid annular plane systolic excursion (TAPSE) | Tricuspid annular plane systolic excursion | Mean | Standard Deviation | cm |
|
| Echocardiography at rest: Left ventricular eccentricity index (LV-EI) | Left ventricular eccentricity index | Value for LV-EI is missing for one participant. | Mean | Standard Deviation | index |
|
| Echocardiography at rest: Fractional area change (FAC) | Fractional area change | Values for FAC are missing for seven participants. | Mean | Standard Deviation | percent |
|
| Echocardiography at rest: Inferior vena cava (IVC) diameter | Inferior vena cava diameter | Mean | Standard Deviation | cm |
|
| Echocardiography at rest: Inferior vena cava (IVC) collapse | Inferior vena cava collapse | Values for IVC collapse are missing for 3 participants. | Mean | Standard Deviation | % |
|
| Echocardiography at rest: Left atrial (LA) diameter | Left atrial diameter | Value for LA diameter is missing for one participant. | Mean | Standard Deviation | cm |
|
| Echocardiography at rest: Diameter of pulmonary artery (PA) | Values for Diameter of pulmonary artery are missing for six participants. | Mean | Standard Deviation | cm |
|
| Echocardiography at rest: Qualitative assesment of left ventricular pump function | Count of Participants | Participants |
|
| Echocardiography at rest: Qualitative assesment of right ventricular pump function | Count of Participants | Participants |
|
| Echocardiography at rest: Left ventricular diastolic dysfunction | Count of Participants | Participants |
|
| Lung function: Forced vital capacity (FVC) | Mean | Standard Deviation | %predicted |
|
| Lung function: Forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | %predicted |
|
| Lung function: Total lung capacity (TLC) | Mean | Standard Deviation | %(predicted) |
|
| Lung function: Residual volume (RV) | Mean | Standard Deviation | %predicted |
|
| Lung function: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Value for DLCO is missing for one participant. | Mean | Standard Deviation | %predicted |
|
| Lung function: Diffusion Capacity corrected for Alveolar Volume (DLCO/VA) | Value for DLCO/VA is missing for one participant. | Mean | Standard Deviation | %predicted |
|
| Laboratory: Hemoglobin | Values for Hemoglobin are missing for two participants. | Mean | Standard Deviation | g/dl |
|
| Laboratory: Hematocrit | Values for Hematocrit are missing for two participants. | Mean | Standard Deviation |
|
| Laboratory: Creatinine | Values for Creatine are missing for two participants. | Mean | Standard Deviation | mg/dl |
|
| Laboratory: Urea | Values for Urea are missing for two participants. | Mean | Standard Deviation | mg/dl |
|
| Laboratory: Uric acid | Values for Uric acid are missing for two participants. | Mean | Standard Deviation | mg/dl |
|
| Laboratory: SGOT | Values for SGOT are missing for two participants. | Mean | Standard Deviation | U/l |
|
| Laboratory: SGPT | Values for SGPT are missing for two participants. | Mean | Standard Deviation | U/l |
|
| Laboratory: CRP | Values for CRP are missing for three participants. | Mean | Standard Deviation | mg/l |
|
| Laboratory: Sodium | Values for Sodium are missing for two participants. | Mean | Standard Deviation | mmol/l |
|
| Laboratory: NTproBNP | Values for NTproBNP are missing for two participants. | Mean | Standard Deviation | ng/l |
|
| CPET: Systolic blood pressure | Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Mean | Standard Deviation | mmHg |
|
| CPET: Diastolic blood pressure | Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | mmHg |
|
| CPET: Heart rate | Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | beats/min |
|
| CPET: Volume of oxygen consumption (VO2) in total | Volume of oxygen consumption | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | ml/min |
|
| CPET: Volume of Oxygen consumption per kg of bodyweight (VO2/kg) | Volume of Oxygen consumption per kg of bodyweight | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Mean | Standard Deviation | ml/min/kg |
|
| CPET: Volume of exhaled carbondioxide (VCO2) | Volume of exhaled carbondioxide | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | ml/min |
|
| CPET: Oxygen saturation (SpO2) | Oxygen saturation | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | percent |
|
| CPET: Minute Ventilation (VE) | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | L/min |
|
| CPET: O2-pulse | Oxygen-pulse | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | ml |
|
| CPET: Equivalents for O2 at rest | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | ratio |
|
| CPET: Respiratory reserve | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | percent |
|
| CPET: workload | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants. | Mean | Standard Deviation | watt |
|
| Laboratory: Bilirubin | Values for Bilirubin are missing for two participants. | Mean | Standard Deviation | mg/dl |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Change in RA (Right Atrial) Area | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | cm^2 | Baseline to 24 weeks |
|
|
|
|
| Secondary | Change in RV (Right Ventricular) Area | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm^2 | baseline to 12 weeks |
|
|
|
| Secondary | Change in RA (Right Atrial) Area | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm^2 | baseline to 12 weeks |
|
|
|
| Secondary | Change in Systolic Pulmonary Artery Pressure (sPAP) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 12 weeks |
|
|
|
| Secondary | Change in Systolic Pulmonary Artery Pressure (sPAP) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 24 weeks |
|
|
|
| Secondary | Change in RV Fractional Area Change (FAC) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | % of end-diastolic area | baseline to 24 weeks |
|
|
|
|
| Secondary | Change in RV Fractional Area Change (FAC) | echocardiographic analysis | Population description: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | % of end-diastolic area | baseline to 12 weeks |
|
|
|
| Secondary | Change in Peak Velocity of Tricuspid Regurgitation (TRV) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | m/s | baseline to 12 weeks |
|
|
|
| Secondary | Change in Peak Velocity of Tricuspid Regurgitation (TRV) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | m/s | baseline to 24 weeks |
|
|
|
| Secondary | Change in Inferior Vena Cava (IVC) Diameter | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | cm | baseline to 24 weeks |
|
|
|
|
| Secondary | Change in Inferior Vena Cava (IVC) Diameter | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm | baseline to 12 weeks |
|
|
|
| Secondary | Change in Right Ventricle Outflow Tract Velocity Time Integral (RVOT VTI) | echocardiographic analysis | RVOT VTI was a pre-specified echocardiographic parameter; however, it was not collected or analyzed in this study due to inherent technical limitations of the echocardiography system used at the study site. As a result, no RVOT VTI data were available for analysis. | Posted | baseline to 12 weeks |
|
|
| Secondary | Change in Eccentricity Index (EI) | Change in left ventricular eccentricity index (LV-EI) from baseline at 24 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perpendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | index | baseline to 24 weeks |
|
|
|
| Secondary | Change in Eccentricity Index (EI) | Change in left ventricular eccentricity index (LV-EI) from baseline at 12 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perpendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | index | baseline to 12 weeks |
|
|
|
| Secondary | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm | baseline to 12 weeks |
|
|
|
| Secondary | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | cm | baseline to 24 weeks |
|
|
|
|
| Secondary | Change in Right Ventricular Pump Function (Qualitative) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 24 weeks |
|
|
|
|
| Secondary | Change in Left Ventricular Pump Function (Qualitative) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 24 weeks |
|
|
|
|
| Secondary | Change in Right Ventricular Pump Function (Qualitative) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 12 weeks |
|
|
|
| Secondary | Change in Left Ventricular Pump Function (Qualitative) | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 12 weeks |
|
|
|
| Secondary | Change in Left Atrial (LA) Diameter | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm | baseline to 12 weeks |
|
|
|
| Secondary | Change in Left Atrial (LA) Diameter | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm | baseline to 24 weeks |
|
|
|
| Secondary | Change in Left Ventricular (LV) Diastolic Function | echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time) | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 12 weeks |
|
|
|
| Secondary | Change in Left Ventricular (LV) Diastolic Function | echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time) | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 12 weeks |
|
|
|
| Secondary | Change in Diameters of Pulmonary Artery (PA) | echocardiographic Analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm | baseline to 12 weeks |
|
|
|
| Secondary | Change in Diameters of Pulmonary Artery (PA) | echocardiographic Analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | cm | baseline to 24 weeks |
|
|
|
| Secondary | Change in Cardiac Index (CI) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | l/min/m^2 | baseline and after 24 weeks |
|
|
|
|
| Secondary | Change in Cardiac Output (CO) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | l/min | baseline and after 24 weeks |
|
|
|
|
| Secondary | Change in Systolic Pulmonary Arterial Pressure (sPAP) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline and after 24 weeks |
|
|
|
| Secondary | Change in Diastolic Pulmonary Arterial Pressure (dPAP) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline and after 24 weeks |
|
|
|
| Secondary | Change in Mean Pulmonary Arterial Pressure (mPAP) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline and after 24 weeks |
|
|
|
| Secondary | Change in Pulmonary Arterial Wedge Pressure (PAWP) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline and after 24 weeks |
|
|
|
| Secondary | Change in Right Atrial Pressure (RAP) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline and after 24 weeks |
|
|
|
| Secondary | Change in Pulmonary Vascular Resistance (PVR) | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | WU | baseline and after 24 weeks |
|
|
|
|
| Secondary | Change in Central Venous Saturation From Pulmonary Artery | Pulmonary hemodynamics by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Percent | baseline and after 24 weeks |
|
|
|
| Secondary | Change in 6-minute Walking Distance | Change in exercise capacity | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | m | baseline to 12 weeks |
|
|
|
| Secondary | Change in 6-minute Walking Distance | Change in exercise capacity | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | m | baseline to 24 weeks |
|
|
|
|
| Secondary | Forced Vital Capacity (FVC) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 12 weeks |
|
|
|
| Secondary | Forced Vital Capacity (FVC) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 24 weeks |
|
|
|
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 12 weeks |
|
|
|
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 24 weeks |
|
|
|
| Secondary | Change in FEV1% of Maximal Vital Capacity (VC Max) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | % predicted | baseline to 12 weeks |
|
|
|
| Secondary | Change in FEV1% of Maximal Vital Capacity (VC Max) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | % predicted | baseline to 24 weeks |
|
|
|
| Secondary | Change in Total Lung Capacity (TLC) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %(predicted) | baseline to 12 weeks |
|
|
|
| Secondary | Change in Total Lung Capacity (TLC) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %(predicted) | baseline to 24 weeks |
|
|
|
| Secondary | Change in Residual Volume (RV) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 12 weeks |
|
|
|
| Secondary | Change in Residual Volume (RV) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 24 weeks |
|
|
|
| Secondary | Change in Diffusion-limited Carbon Monoxide (DLCO) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 24 weeks |
|
|
|
| Secondary | Change in Diffusion-limited Carbon Monoxide (DLCO) | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 12 weeks |
|
|
|
| Secondary | Change in DLCO/VA (Krogh) Factor | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 12 weeks |
|
|
|
| Secondary | Change in DLCO/VA (Krogh) Factor | Change in Lung function Tests | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | %predicted | baseline to 24 weeks |
|
|
|
| Secondary | Change in Partial Pressure of Oxygen (pO2) | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 12 weeks |
|
|
|
| Secondary | Change in Partial Pressure of Oxygen (pO2) | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 24 weeks |
|
|
|
| Secondary | Change in Partial Pressure of Carbon Dioxide (pCO2) | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 12 weeks |
|
|
|
| Secondary | Change in Partial Pressure of Carbon Dioxide (pCO2) | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 24 weeks |
|
|
|
| Secondary | Change in Oxygen Saturation (SaO2) | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | percent | baseline to 12 weeks |
|
|
|
| Secondary | Change in Oxygen Saturation (SaO2) | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | percent | baseline to 24 weeks |
|
|
|
| Secondary | Change in pH | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | pH | baseline to 24 weeks |
|
|
|
| Secondary | Change in pH | Change in capillary or arterial blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | pH | baseline to 12 weeks |
|
|
|
| Secondary | Change in Blood Pressure | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally, visit 2 was skipped for several patients which further reduced the number of evaluable patients. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | mmHg | baseline to 12 weeks |
|
|
|
| Secondary | Change in Blood Pressure | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | mmHg | baseline to 24 weeks |
|
|
|
| Secondary | Change in Heart Rate | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which further reduced the number of participants that performed CPET after 12 weeks . Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | beats/min | baseline to 12 weeks |
|
|
|
| Secondary | Change in Heart Rate | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | beats/min | baseline to 24 weeks |
|
|
|
| Secondary | Change in Workload | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | watt | baseline to 12 weeks |
|
|
|
| Secondary | Change in Workload | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | watts | baseline to 24 weeks |
|
|
|
| Secondary | Change in Oxygen Consumption as Total (VO2) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | ml/min | baseline to 24 weeks |
|
|
|
| Secondary | Change in Oxygen Consumption as Total (VO2) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | ml/min | baseline to 12 weeks |
|
|
|
| Secondary | Change in Exhaled Carbon Dioxide (VCO2) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally, visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.. | Posted | Mean | Standard Deviation | ml/min | baseline to 12 weeks |
|
|
|
| Secondary | Change in Exhaled Carbon Dioxide (VCO2) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | ml/min | baseline to 24 weeks |
|
|
|
| Secondary | Change in Oxygen Saturation (SpO2) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | percent | baseline to 12 weeks |
|
|
|
| Secondary | Change in Oxygen Saturation (SpO2) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | percent | baseline to 24 weeks |
|
|
|
| Secondary | Change in Oxygen Pulse | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | ml/beat | baseline to 12 weeks |
|
|
|
| Secondary | Change in Oxygen Pulse | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | ml/beat | baseline to 24 weeks |
|
|
|
| Secondary | Change in Minute Ventilation (VE) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | L/min | baseline to 12 weeks |
|
|
|
| Secondary | Change in Minute Ventilation (VE) | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | L/min | baseline to 24 weeks |
|
|
|
| Secondary | Change in Respiratory Equivalents for Oxygen at Rest | Change in Cardiopulmonary exercise testing: The respiratory equivalent for oxygen represents the ratio of minute ventilation (VE) to oxygen uptake (VO₂) and reflects the efficiency of ventilation relative to oxygen consumption. | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | ratio | baseline to 12 weeks |
|
|
|
| Secondary | Change in Respiratory Equivalents for Oxygen at Rest | Change in Cardiopulmonary exercise testing: The respiratory equivalent for oxygen represents the ratio of minute ventilation (VE) to oxygen uptake (VO₂) and reflects the efficiency of ventilation relative to oxygen consumption. | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | ratio | baseline to 24 weeks |
|
|
|
| Secondary | Change in Respiratory Equivalents for Carbon Dioxide | Change in Cardiopulmonary exercise testing: The respiratory equivalent for carbon dioxide represents the ratio of minute ventilation (VE) to carbon dioxide production (VCO₂) and reflects ventilatory efficiency with respect to carbon dioxide elimination. | This measurement was not implemented during the study period, and therefore no data were collected. Consequently, no analysis is possible and none is planned. | Posted | baseline to 12 weeks |
|
|
| Secondary | Change in Respiratory Equivalents for Carbon Dioxide | Change in Cardiopulmonary exercise testing: The respiratory equivalent for carbon dioxide represents the ratio of minute ventilation (VE) to carbon dioxide production (VCO₂) and reflects ventilatory efficiency with respect to carbon dioxide elimination. | This measurement was not implemented during the study period, and therefore no data were collected. Consequently, no analysis is possible and none is planned. | Posted | baseline to 24 weeks |
|
|
| Secondary | Change in Respiratory Reserve | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | percent respiratory reserve | baseline to 12 weeks |
|
|
|
| Secondary | Change in Respiratory Reserve | Change in Cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | percent respiratory reserve | baseline to 24 weeks |
|
|
|
| Secondary | WHO FC | Change in WHO functional class | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 12 weeks |
|
|
|
| Secondary | WHO FC | Change in WHO functional class | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Count of Participants | Participants | baseline to 24 weeks |
|
|
|
|
| Secondary | NT-proBNP | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | ng/l | baseline to 12 weeks |
|
|
|
| Secondary | NT-proBNP | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | Standard Deviation | ng/l | baseline to 24 weeks |
|
|
|
|
| Secondary | Haemoglobin Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | g/dl | baseline to 12 weeks |
|
|
|
| Secondary | Haemoglobin Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | g/dl | baseline to 24 weeks |
|
|
|
| Secondary | Haematocrit Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Ratio | baseline to 12 weeks |
|
|
|
| Secondary | Haematocrit Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Ratio | baseline to 24 weeks |
|
|
|
| Secondary | SGOT/AST Changes | Change in liver enzymes | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | U/l | baseline to 12 weeks |
|
|
|
| Secondary | SGOT/AST Changes | Change in liver enzymes | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | U/l | baseline to 24 weeks |
|
|
|
| Secondary | SGPT/ALT Changes | Change in liver enzymes | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | U/l | baseline to 12 weeks |
|
|
|
| Secondary | SGPT/ALT Changes | Change in liver enzymes | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | U/l | baseline to 24 weeks |
|
|
|
| Secondary | Bilirubin Changes | Change in liver enzymes | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline to 12 weeks |
|
|
|
| Secondary | Bilirubin Changes | Change in liver enzymes | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline to 24 weeks |
|
|
|
| Secondary | CRP Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/l | baseline to 12 weeks |
|
|
|
| Secondary | CRP Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/l | baseline to 24 weeks |
|
|
|
| Secondary | Sodium Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmol/l | baseline to 12 weeks |
|
|
|
| Secondary | Sodium Changes | Change in laboratory parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mmol/l | baseline to 24 weeks |
|
|
|
| Secondary | Urea Changes | Change in renal parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline to 12 weeks |
|
|
|
| Secondary | Urea Changes | Change in renal parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline to 24 weeks |
|
|
|
| Secondary | Creatinine Changes | Change in renal parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline to 12 weeks |
|
|
|
| Secondary | Creatinine Clearance Changes | Change in renal parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | ml/min | baseline to 12 weeks |
|
|
|
| Secondary | Creatinine Changes | Change in renal parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline to 24 weeks |
|
|
|
| Secondary | Creatinine Clearance Changes | Change in renal parameters | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | ml/min | baseline to 24 weeks |
|
|
|
| Secondary | Change in IVC Collapse | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | percent | baseline to 12 weeks |
|
|
|
| Secondary | Change in IVC Collapse | echocardiographic analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | percent | baseline to 24 weeks |
|
|
|
|
| Secondary | SF-36: Physical Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Physical Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Pain | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: General Health Perception | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Vitality | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Social Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Emotional Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Mental Well-being | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Physical Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Mental Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 24 weeks |
|
|
|
| Secondary | SF-36: Physical Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Physical Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Pain | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: General Health Perception | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Vitality | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Social Functioning | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Emotional Role Function | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Mental Well-being | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Physical Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | SF-36: Mental Summation Score | Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures. | Posted | Mean | 95% Confidence Interval | Scores on a scale | baseline to 12 weeks |
|
|
|
| Secondary | Change in Oxygen Consumption Per kg Body Weight (VO2/kg) | Change in Cardiopulmonary Exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | 95% Confidence Interval | ml/min/kg | Baseline to 24 weeks |
|
|
|
| Secondary | Change in Oxygen Consumption Per kg Body Weight (VO2/kg) | Change in cardiopulmonary exercise testing | CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally, visit 2 was skipped for several patients which further reduced the number of evaluable patients. Thus the analysis was only possible for a reduced number of participants. | Posted | Mean | Standard Deviation | ml/min/kg | Baseline to 12weeks |
|
|
|
| Secondary | Change in Right Ventricle Outflow Tract Velocity Time Integral (RVOT VTI) | echocardiographic analysis | RVOT VTI was a pre-specified echocardiographic parameter; however, it was not collected or analyzed in this study due to inherent technical limitations of the echocardiography system used at the study site. As a result, no RVOT VTI data were available for analysis. | Posted | baseline to 24 weeks |
|
|
| 0 |
| 30 |
| 3 |
| 30 |
| 29 |
| 30 |
| Vitreous hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Corneal edema | Eye disorders | MedDRA | Non-systematic Assessment |
|
| Respiratory infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Infection with hypoxemia | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| PAH progression | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Edema | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Unspecified circulatory system disorder | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
|
| Covid-19 | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Respiratory infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Vitamin D defiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sleep disorders | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| RV-function deterioration (-1) |
|
|
| Diastolic blood pressure at rest |
|
| Diastolic blood pressure at anaerobic threshold |
|
| Diastolic blood pressure at peak workload |
|
|
| Systolic blood pressure at peak workload |
|
|
| Diastolic blood pressure at rest |
|
|
| Diastolic blood pressure at anaerobic threshold |
|
|
| Diastolic blood pressure at peak workload |
|
|
| Title | Measurements |
|---|---|
|
|
| Heart rate at peak workload |
|
|
|
|
| VO2 at peak workload |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| VCO2 at peak workload |
|
|
| Title | Measurements |
|---|---|
|
|
| SpO2 at peak workload |
|
|
| Title | Measurements |
|---|---|
|
|
| O2-pulse at peak workload |
|
|
|
|
| Minute ventilation at peak workload |
|
|
| Respiratory reserve at peak workload |
|
|
| Respiratory reserve at peak workload |
|
|
| Unchanged |
|
|
| VO2/kg at peak workload |
|
|
| Title | Measurements |
|---|---|
|