TrEatment Approach in the Multimodal Era Registry

Last updated: January 14, 2025
Sponsor: International CTEPH Association
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Stress

Williams Syndrome

Treatment

Pulmonary endarterectomy

Pulmonary hypertension (PH)-specific medication

Balloon pulmonary angioplasty

Clinical Study ID

NCT05629052
TEAM registry
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:

  2. Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonaryvascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2WU at rest, have exercise limitations from CTEPD without PH

  3. Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographicpulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPDas recommended by standard guidelines

  4. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPDwithout PH

  5. Naïve to interventional treatment (both PEA and BPA)

  6. Pre-treatment with PH-specific medication for ≤ 12 months, or no medicalpre-treatment, at enrollment

  7. Willing and able to provide informed consent in order to participate in the study (informed consent signed)

  8. Age ≥ 18 years

  9. CTEPH-specific treatment must be modified or initiated at the participating site

Exclusion

Exclusion Criteria:

  1. Main cause of PH other than CTEPH

  2. Participating in an interventional clinical trial at enrollment

Study Design

Total Participants: 1000
Treatment Group(s): 3
Primary Treatment: Pulmonary endarterectomy
Phase:
Study Start date:
April 12, 2023
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Hospital Universitario Fundación Favaloro

    Buenos Aires, C1093AAS
    Argentina

    Active - Recruiting

  • University Hospital Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Santa Casa

    Porto Alegre, RS 90035-074
    Brazil

    Active - Recruiting

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • China-Japan Friendship Hospital

    Beijing, 100020
    China

    Active - Recruiting

  • Shaio Clinic Foundation

    Bogotá, 111121
    Colombia

    Active - Recruiting

  • General University Hospital

    Prague, 12808
    Czech Republic

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Kerckhoff Clinic, Department of Thoracic Surgery

    Bad Nauheim, 61231
    Germany

    Active - Recruiting

  • Narayana Institute of Cardiac Science

    Bangalore, 560099
    India

    Active - Recruiting

  • University of Bologna

    Bologna, 40126
    Italy

    Active - Recruiting

  • Okayama Medical Center

    Okayama, 701-1192
    Japan

    Active - Recruiting

  • National Cerebral and Cardiovascular Center

    Osaka, 564-8565
    Japan

    Active - Recruiting

  • National Heart Institute

    Mexico City, 14080
    Mexico

    Active - Recruiting

  • Department of Cardiac and Vascular Diseases, John Paul II Hospital

    Kraków, 31-202
    Poland

    Active - Recruiting

  • Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock

    Otwock, 05-400
    Poland

    Active - Recruiting

  • National Heart Centre of Singapore

    Singapore, 168582
    Singapore

    Active - Recruiting

  • Pulmonary Hypertension Unit, Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Marmara University School of Medicine

    Istanbul, 34899
    Turkey

    Active - Recruiting

  • Royal Papworth Hospital

    Cambridge, CB2 0AY
    United Kingdom

    Site Not Available

  • University of California San Diego

    San Diego, California 92037
    United States

    Active - Recruiting

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • UT Southwestern

    Dallas, Texas 75390
    United States

    Active - Recruiting

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