TrEatment Approach in the Multimodal Era Registry
- Conditions
- Chronic Thromboembolic Pulmonary HypertensionCTEPH
- Registration Number
- NCT05629052
- Lead Sponsor
- International CTEPH Association
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
-
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
- Main cause of PH other than CTEPH
- Participating in an interventional clinical trial at enrollment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year survival 3 years after last intervention Proportion of patients alive 3 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Utilization and combination of treatment modalities Min. 3 years Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities
- Secondary Outcome Measures
Name Time Method Reason why PEA was not performed Min. 3 years The main reason why PEA was not performed as chosen by the investigator from a list of pre-defined reasons
1-year survival 1 year after last intervention Proportion of patients alive 1 year after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Changes in PH-specific medication Min. 3 years Proportion of patients experiencing a change in PH-specific medication during the study
Reason why BPA was not performed Min. 3 years The main reason why BPA was not performed as chosen by the investigator from a list of pre-defined reasons
Complications of treatment interventions (per patient) Min. 3 years Proportion of patients experiencing complications from BPA or PEA
Complications of treatment interventions (per BPA session) Min. 3 years Proportion of BPA sessions associated with complications
5-year survival 5 year after last intervention Proportion of patients alive 5 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment
Trial Locations
- Locations (25)
Pulmonary Hypertension Unit, Hospital 12 de Octubre
🇪🇸Madrid, Spain
Marmara University School of Medicine
🇹🇷Istanbul, Turkey
Narayana Institute of Cardiac Science
🇮🇳Bangalore, India
University of Bologna
🇮🇹Bologna, Italy
Okayama Medical Center
🇯🇵Okayama, Japan
National Heart Institute
🇲🇽Mexico City, Mexico
China-Japan Friendship Hospital
🇨🇳Beijing, China
Shaio Clinic Foundation
🇨🇴Bogotá, Colombia
General University Hospital
🇨🇿Prague, Czech Republic
Aarhus University Hospital
🇩🇰Aarhus, Denmark
University of California San Diego
🇺🇸San Diego, California, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Duke University
🇺🇸Durham, North Carolina, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Hospital Universitario Fundación Favaloro
🇦🇷Buenos Aires, Argentina
University Hospital Vienna
🇦🇹Vienna, Austria
University Hospitals Leuven
🇧🇪Leuven, Belgium
Santa Casa
🇧🇷Porto Alegre, Brazil
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Kerckhoff Clinic, Department of Thoracic Surgery
🇩🇪Bad Nauheim, Germany
National Cerebral and Cardiovascular Center
🇯🇵Osaka, Japan
Department of Cardiac and Vascular Diseases, John Paul II Hospital
🇵🇱Kraków, Poland
Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock
🇵🇱Otwock, Poland
National Heart Centre of Singapore
🇸🇬Singapore, Singapore
Royal Papworth Hospital
🇬🇧Cambridge, United Kingdom