TrEatment Approach in the Multimodal Era Registry

NCT05629052 · tracked via the Priya Life Science China tracker

Sponsor

International CTEPH Association

Phase

Observational

Started

2023-04-12

Last updated

2025-05-08

Condition(s) studied

Chronic Thromboembolic Pulmonary HypertensionCTEPH

Investigational drug(s) / intervention(s)

Pulmonary endarterectomyBalloon pulmonary angioplastyPulmonary hypertension (PH)-specific medication

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

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

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Utilization and combination of treatment modalities — Min. 3 years
Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities
3-year survival — 3 years after last intervention
Proportion of patients alive 3 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment

Trial sites (25)

Facility	City	Region
University of California San Diego	San Diego	California
Northwestern University	Evanston	Illinois
Duke University	Durham	North Carolina
UT Southwestern	Dallas	Texas
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
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

Other trials for the same condition

Chinese PE Multimodality Imaging Artificial Intelligence Study Recruiting

Safety and Efficacy of Balloon Pulmonary Angioplasty in China Recruiting

Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART) Recruiting

the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension Recruiting

Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05629052 on ClinicalTrials.gov ↗ ← All trials in China