TrEatment Approach in the Multimodal Era Registry (TEAM)

International CTEPH Association

Status: Active, not recruiting

Conditions: CTEPH; Chronic Thromboembolic Pulmonary Hypertension

Treatments: Drug: Pulmonary hypertension (PH)-specific medication; Procedure: Pulmonary endarterectomy; Procedure: Balloon pulmonary angioplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05629052

TEAM registry

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

1. Main cause of PH other than CTEPH
2. Participating in an interventional clinical trial at enrollment