NCT05629052Active, not recruiting
TrEatment Approach in the Multimodal Era Registry
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: * surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) * the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) * drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: * How many patients receive a given kind of treatment? * How do expert centers combine the different treatments? * Are patients doing better after they receive a given kind of treatment? * How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 17 Nov 2022
- Start date
- 12 Apr 2023
- Primary completion date
- Apr 2028
- Lead sponsor
- International CTEPH Association
- NCT number
- NCT05629052
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 12 Apr 2023 to the primary completion date, Apr 2028
- 25 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Main cause of PH other than CTEPH
- Participating in an interventional clinical trial at enrollment
Who the study is looking for
- Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:
- Mean pulmonary arterial pressure (mPAP) \> 20 mmHg at rest with pulmonary vascular resistance (PVR) \> 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from CTEPD without PH
- Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
- Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
- Naïve to interventional treatment (both PEA and BPA)
- Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
- Willing and able to provide informed consent in order to participate in the study (informed consent signed)
- Age ≥ 18 years
- CTEPH-specific treatment must be modified or initiated at the participating site
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Fundación Favaloro Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| University Hospital Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Santa Casa Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Shaio Clinic Foundation Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
| General University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Kerckhoff Clinic, Department of Thoracic Surgery Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Pulmonary Hypertension Unit, Hospital 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Royal Papworth Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Narayana Institute of Cardiac Science Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| University of Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Okayama Medical Center Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| National Cerebral and Cardiovascular Center Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| National Heart Institute Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Department of Cardiac and Vascular Diseases, John Paul II Hospital Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock Coordinator of this site? Confirm its status | Otwock | Poland | Unknown status |
| National Heart Centre of Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| UT Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Marmara University School of Medicine Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.