TrEatment Approach in the Multimodal Era Registry (NCT05629052) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TrEatment Approach in the Multimodal Era Registry
United States, Argentina1,000 participantsStarted 2023-04-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
What they're measuring
1
Utilization and combination of treatment modalities