Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1000 participants
OBSERVATIONAL
2023-04-12
2028-04-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Pulmonary endarterectomy
Surgical removal of a chronic clot from the pulmonary artery
Balloon pulmonary angioplasty
Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon
Pulmonary hypertension (PH)-specific medication
Treatment with any PH-specific medication, i.e. endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, drugs acting on the prostanoid pathway and prostaglandin I2 receptor agonists
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. 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
2. Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
3. Naïve to interventional treatment (both PEA and BPA)
4. Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
5. Willing and able to provide informed consent in order to participate in the study (informed consent signed)
6. Age ≥ 18 years
7. CTEPH-specific treatment must be modified or initiated at the participating site
Exclusion Criteria
2. Participating in an interventional clinical trial at enrollment
18 Years
ALL
No
Sponsors
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Janssen Pharmaceuticals
INDUSTRY
International CTEPH Association
OTHER
Responsible Party
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Principal Investigators
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Nick H Kim, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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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
China-Japan Friendship Hospital
Beijing, , China
Shaio Clinic Foundation
Bogotá, , Colombia
General University Hospital
Prague, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Kerckhoff Clinic, Department of Thoracic Surgery
Bad Nauheim, , Germany
Narayana Institute of Cardiac Science
Bangalore, , India
University of Bologna
Bologna, , Italy
Okayama Medical Center
Okayama, , Japan
National Cerebral and Cardiovascular Center
Osaka, , Japan
National Heart Institute
Mexico City, , Mexico
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, , Poland
Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock
Otwock, , Poland
National Heart Centre of Singapore
Singapore, , Singapore
Pulmonary Hypertension Unit, Hospital 12 de Octubre
Madrid, , Spain
Marmara University School of Medicine
Istanbul, , Turkey (Türkiye)
Royal Papworth Hospital
Cambridge, , United Kingdom
Countries
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Related Links
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Description of the registry on the website of the International CTEPH Association
Other Identifiers
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TEAM registry
Identifier Type: -
Identifier Source: org_study_id
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