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The study was stopped due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic, both of which made study completion within a reasonable timeframe appear unlikely.
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This is a randomised, double-blind, placebo-controlled, multicentre, multinational, prospective study in patients with operable chronic thromboembolic pulmonary hypertension (CTEPH) prior to pulmonary endarterectomy (PEA) with high preoperative pulmonary vascular resistance (PVR). Patients will be randomised in a 1:1 ratio to receive riociguat or matching placebo for 3 months before undergoing PEA. The primary objective of this study is to assess the efficacy of riociguat on preoperative PVR compared to placebo in patients with operable CTEPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat | Active Comparator | Patients will receive riociguat for 3 months followed by pulmonary endarterectomy. |
|
| Placebo | Placebo Comparator | Patients will receive placebo for 3 months followed by pulmonary endarterectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat | Drug | Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid. Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA) | Pulmonary vascular resistance (PVR) will be assessed at baseline and immediately before pulmonary endarterectomy. The change in PVR will be assessed as percentage. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA) | Pulmonary vascular resistance (PVR) will be assessed at baseline and 6 months post pulmonary endarterectomy (PEA). The change in PVR will be assessed as percentage. | 270 days |
| Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 90 days |
| Change in NT-proBNP From Baseline Until 6 Months Post-surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Jenkins, MD | Papworth Hospital NHS Foundation Trust, Cambridge, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92037-7892 | United States | ||
| Hopital de Bicêtre |
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| Label | URL |
|---|---|
| Website of the International CTEPH Association | View source |
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IPD sharing is not foreseen
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Eligible patients were recruited at 3 expert centers for CTEPH in France, Germany and the UK between August 2018 and May 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Riociguat | Patients will receive riociguat for 3 months followed by pulmonary endarterectomy. Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid. Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability. PEA will be performed at the end of medical treatment (Day 90) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Apr 26, 2018 | Apr 23, 2021 |
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Double-blind
|
|
| Placebo | Drug | Placebo will be given analogue to riociguat with matching tablets. |
|
| Pulmonary endarterectomy | Procedure | PEA will be performed at the end of medical treatment (Day 90) |
|
|
All deaths occurring post-randomization until the last visit will be included. All PH-related hospitalizations except the in-hospital care during and after pulmonary endarterectomy (PEA) from randomization until 6 months after PEA will be included. The worst value for World Health Organization (WHO) functional class after treatment will be used. |
| 270 days |
| Intraoperative Circulatory Arrest Time | Circulatory arrest time will be measured in minutes | intraoperative |
| Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint) | The occurrence of any of the following complications will be assessed:
| intraoperative |
| Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | Classed as easier than normal (1); normal (2); more difficult than normal (3) | intraoperative |
| Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | Classed as better than expected (1); as expected (2); worse than expected (3) | intraoperative |
| Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | Classed as more solid than usual (1); normal (2); more friable than usual (3) | intraoperative |
| Number of Patients Who Died During the Course of the Study | All deaths occurring during the whole course of the study | 270 days |
| Patients Who Withdraw During the Randomized Treatment Phase | Only withdrawals after randomization but before PEA will be included | 90 days |
Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study |
| 270 days |
| Change in Cardiac Index From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 90 days |
| Change in Cardiac Index From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 270 days |
| Change in Mean Right Atrial Pressure From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 90 days |
| Change in Mean Right Atrial Pressure From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 270 days |
| Change in Mean Pulmonary Atrial Pressure From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 90 days |
| Change in Mean Pulmonary Atrial Pressure From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 270 days |
| Change in Pulmonary Artery Wedge Pressure From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 90 days |
| Change in Pulmonary Artery Wedge Pressure From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 270 days |
| Length of Hospital Stay for Pulmonary Endarterectomy | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | intraoperative |
| Length of Intensive Care Unit Stay for Pulmonary Endarterectomy | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | intraoperative |
| WHO Functional Class at the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 90 days |
| WHO Functional Class 6 Months Post Pulmonary Endarterectomy | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 270 days |
| Need for PAH-targeted Therapy 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | 270 days |
| Paris |
| France |
| Kerckhoff-Klinik GmbH | Bad Nauheim | 61231 | Germany |
| Papworth Hospital | Cambridge | CB3 8RE | United Kingdom |
| FG001 | Placebo | Patients will receive placebo for 3 months followed by pulmonary endarterectomy. Placebo will be given analogue to riociguat with matching tablets. PEA will be performed at the end of medical treatment (Day 90) |
| Started Treatment |
|
| Underwent PEA |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least one dose of randomized study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Riociguat | Patients will receive riociguat for 3 months followed by pulmonary endarterectomy. Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid. Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability. PEA will be performed at the end of medical treatment (Day 90) |
| BG001 | Placebo | Patients will receive placebo for 3 months followed by pulmonary endarterectomy. Placebo will be given analogue to riociguat with matching tablets. PEA will be performed at the end of medical treatment (Day 90) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| PVR at diagnosis | Mean | Standard Deviation | dyn*sec/cm^5 |
| |||||||||||||||
| Mean pulmonary arterial pressure (mPAP) at diagnosis | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Received beta blockers between enrollment and PEA | Count of Participants | Participants |
| ||||||||||||||||
| Received vitamin K antagonists between enrollment and PEA | Count of Participants | Participants |
| ||||||||||||||||
| Received new/direct oral anticoagulants between enrollment and PEA | Count of Participants | Participants |
|
| 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 From Baseline in Pulmonary Vascular Resistance (PVR) to Immediately Before Pulmonary Endarterectomy (Pre-PEA) | Pulmonary vascular resistance (PVR) will be assessed at baseline and immediately before pulmonary endarterectomy. The change in PVR will be assessed as percentage. | All participants who received at least one dose of randomized study drug and underwent PEA before study termination | Posted | Mean | Standard Deviation | percentage of baseline PVR | 90 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pulmonary Vascular Resistance (PVR) to 6 Months Post Pulmonary Endarterectomy (PEA) | Pulmonary vascular resistance (PVR) will be assessed at baseline and 6 months post pulmonary endarterectomy (PEA). The change in PVR will be assessed as percentage. | All participants who received at least one dose of randomized study drug and completed the study prior to study termination | Posted | Mean | Standard Deviation | percentage of baseline PVR | 270 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Either All-cause Death, PH-related Hospitalization, Need for PAH-targeted Therapy or WHO Functional Class Unchanged or Worse Between Randomization and 6 Months Post Pulmonary Endarterectomy (Composite Endpoint) | All deaths occurring post-randomization until the last visit will be included. All PH-related hospitalizations except the in-hospital care during and after pulmonary endarterectomy (PEA) from randomization until 6 months after PEA will be included. The worst value for World Health Organization (WHO) functional class after treatment will be used. | All participants who underwent PEA before study termination | Posted | Count of Participants | Participants | 270 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intraoperative Circulatory Arrest Time | Circulatory arrest time will be measured in minutes | All participants who underwent PEA before study termination | Posted | Mean | Standard Deviation | minutes | intraoperative |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Intraoperative Surgery-related Complications (Composite Endpoint) | The occurrence of any of the following complications will be assessed:
| All participants who underwent PEA before study termination | Posted | Count of Participants | Participants | intraoperative |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Surgical Evaluation of Specimen: Stratification of Patients According to Ease of Dissection Plane | Classed as easier than normal (1); normal (2); more difficult than normal (3) | All participants who underwent PEA | Posted | Count of Participants | Participants | intraoperative |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Surgical Evaluation of Specimen: Stratification of Patients According to Completeness of Disease Clearance | Classed as better than expected (1); as expected (2); worse than expected (3) | All participants who underwent PEA before study termination | Posted | Count of Participants | Participants | intraoperative |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Surgical Evaluation of Specimen: Stratification of Patients According to Appearance of Clot and Vessel Wall | Classed as more solid than usual (1); normal (2); more friable than usual (3) | All participants who underwent PEA before study termination | Posted | Count of Participants | Participants | intraoperative |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Died During the Course of the Study | All deaths occurring during the whole course of the study | All participants who underwent PEA before study termination | Posted | Count of Participants | Participants | 270 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients Who Withdraw During the Randomized Treatment Phase | Only withdrawals after randomization but before PEA will be included | All participants who received at least one dose of randomized study drug | Posted | Count of Participants | Participants | 90 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in NT-proBNP From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 90 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in NT-proBNP From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Cardiac Index From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 90 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Cardiac Index From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Mean Right Atrial Pressure From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 90 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Mean Right Atrial Pressure From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Mean Pulmonary Atrial Pressure From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 90 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Mean Pulmonary Atrial Pressure From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Pulmonary Artery Wedge Pressure From Baseline Until the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 90 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Pulmonary Artery Wedge Pressure From Baseline Until 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Length of Hospital Stay for Pulmonary Endarterectomy | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | intraoperative | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Length of Intensive Care Unit Stay for Pulmonary Endarterectomy | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | intraoperative | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | WHO Functional Class at the End of Medical Treatment | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 90 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | WHO Functional Class 6 Months Post Pulmonary Endarterectomy | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Need for PAH-targeted Therapy 6 Months Post-surgery | Data are not reported for this exploratory endpoint because of limited sample size due to early termination of the study | Not Posted | 270 days | Participants |
From informed consent until study completion (typically 9-12 months) or early termination
Events reported are treatment-emergent adverse events, i.e. any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to study drug, in patients who actually received any study drug. Events were identified by investigator assessment at each visit, and from study data. All-cause mortality is reported based on all patients enrolled, including one patient who died prior to initiating treatment.
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 | Patients will receive riociguat for 3 months followed by pulmonary endarterectomy. Riociguat will be initiated at 1 mg. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid. Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability. PEA will be performed at the end of medical treatment (Day 90) | 0 | 7 | 1 | 7 | 7 | 7 |
| EG001 | Placebo | Patients will receive placebo for 3 months followed by pulmonary endarterectomy. Placebo will be given analogue to riociguat with matching tablets. PEA will be performed at the end of medical treatment (Day 90) | 1 | 7 | 2 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mediastinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment | Worsening symptoms of CTEPH, including increased NT-proBNP, peripheral oedema and breathlessness |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Inflammatory marker increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Drug therapy | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
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The study was terminated after enrolling only 14 out of 88 planned patients, due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic. No firm conclusions can be drawn based on the study data due to the limited sample size.
Both the International CTEPH Association and the financial sponsor can review results communications prior to public release and can embargo communications regarding trial results for up to 180 days from submission for review
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Jenkins, MD; Principal Investigator and ICA Board member | Papworth Hospital NHS Foundation Trust | +44 1223 638000 | david.jenkins1@nhs.net |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2020 | Apr 23, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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