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The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.
Planned observation duration per patient is a minimum of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TripleTRE NIS patients | all patients previously treated within the TripleTRE trial who are willing to participate in this NIS |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to death or lung transplantation | up to year 3 | |
| Time to first clinical worsening | clinical worsening is defined as fulfilling on of the following criteria:
| up to year 3 |
| Total number of clinical worsenings | clinical worsening is defined as fulfilling on of the following criteria:
| up to year 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term change in 6MWD | 6-Minute Walking Distance (6MWD) will be measured in meters | up to year 3 |
| Long-term change in PAH treatment regimens | any change or addition of new PH medication including dosing in time |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and seriousness of adverse events (AE) and adverse drug reactions (ADR) | This includes:
| up to year 3 |
| Long-term change in QoL using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire |
Inclusion Criteria:
1. Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS
Exclusion Criteria:
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The study population will consist of patients who participated in the TripleTRE study and who have not been lost to follow-up and have given a written informed consent for their participation in the NIS.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordensklinikum Linz | Linz | Austria | ||||
| Medical University Vienna |
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| up to year 3 |
| Long-term change in risk status | Risk status measured by simplified four-strata risk-assessment tool | up to year 3 |
| Long-term change in WHO FC | World Health Organization Functional Class (WHO FC) is categorized from I (no symptoms) to IV (severe dyspnea and symptoms) | up to year 3 |
| Long-term change in BDS | BDS - Borg Dyspnea Score, ranging from 0 (no exertion) to 10 (maximum) | up to year 3 |
| Long-term change in NT-proBNP/BNP | NT-proBNP/BNP: N-terminal pro Brain Natriuretic Peptide | up to year 3 |
| Long-term change in Pulmonary Vascular Resistance (PVR) | PVR to be measured in WU Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in mean Pulmonary Arterial Pressure (mPAP) | mPAP to be measured in mmHg Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Right Atrial Pressure (RAP) | RAP to be measured in mmHg Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in mean Right Atrial Pressure (mRAP) | mean Right Atrial Pressure (mRAP) to be measured in mmHg Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Cardiac Index (CI) | Cardiac index (CI) measured in liters per minute per square meter Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Cardiac Output (CO) | Cardiac output (CO) measured in liters per minute Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Pulmonary capillary wedge pressure (PCWP) | Pulmonary capillary wedge pressure (PCWP) measured in mmHg Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Stroke volume index (SVI) | Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in RV-PA coupling | RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in RV end-diastolic area (RVEDA) | RV end-diastolic area (RVEDA) measured in square centimeters Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in RV end-systolic area (RVESA) | RV end-systolic area (RVESA) measured in square centimeters Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in RV fractional area change (RVFAC) | RV fractional area change (RVFAC) calculated in % Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Right Atrium (RA) area | Right Atrium (RA) area in square centimeters Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Pericardial effusion | Pericardial effusion assessment will be done and rated as yes/no Parameter will be collected according to clinical routine | up to year 3 |
| Long-term change in Right ventricular ejection fraction (RVEF) | Parameter will be collected according to clinical routine | up to year 3 |
The EQ-5D-5L questionnaire consists of 2 parts - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score. |
| up to year 3 |
| Long-term change in QoL using PAH-specific emPHasis-10 questionnaire | Emphasis meaning something of special importance or significance. Please translate using the most appropriate term. The PH in emPHasis represents the condition Pulmonary Hypertension. The number 10 refers to the number of items in the questionnaire. This questionnaire is designed to determine how Pulmonary Hypertension (PH) affects patient's life. It refers to how PH affects or the impact that PH has on the patient's life. | up to year 3 |
| Vienna |
| Austria |
| Fakultní Nemocnice Olomouc | Olomouc | Czechia |
| Všeobecná fakultní nemocnice v Praze | Prague | Czechia |
| Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris | Paris | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| DRK Kliniken Berlin Westend | Berlin | Germany |
| University Hospital Carl Gustav Carus of Technical University Dresden | Dresden | Germany |
| Universitätsmedizin Greifswald | Greifswald | Germany |
| Gottsegen National Cardiovascular lnstitute | Budapest | Hungary |
| Medical University of Szeged | Szeged | Hungary |
| Sapienza University of Rome | Rome | Italy |
| John Paul II Hospital Krakow | Krakow | Poland |
| Fryderyk Chopin Hospital in European Health Centre Otwock | Otwock | Poland |
| Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu | Bucharest | Romania |
| Emergency Clinical County Hospital of Targu Mures | Târgu Mureş | Romania |
| Hospital Clinic of Barcelona | Barcelona | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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