NCT05629052

TrEatment Approach in the Multimodal Era Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: International CTEPH Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension
• CTEPH

Interventions

Type	Name	Description
PROCEDURE	Pulmonary endarterectomy	Surgical removal of a chronic clot from the pulmonary artery
PROCEDURE	Balloon pulmonary angioplasty	Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon
DRUG	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

Timeline

• Start date: 2023-04-12
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2022-11-29
• Last updated: 2025-05-08

Locations

25 sites across 20 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Singapore, Spain, Turkey (Türkiye), United Kingdom