Status:
RECRUITING
Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Chronic Thromboembolic Pulmonary Hypertension
Eligibility:
All Genders
14+ years
Brief Summary
The Change Database is a prospective, observational multi-center disease registry, which will collect data on patients with chronic thromboembolic pulmonary hypertension (CTEPH) in China. It aims to i...
Detailed Description
18 CTEPH centers will be enrolled in the study. The epidemiology, diagnosis，treatments (pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and targeted medical therapy), and long-term...
Eligibility Criteria
Inclusion
- Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
- Patients must be willing to provide informed consent
- Patients must meet the following criteria for CTEPH:
- a mean pulmonary artery pressures (mPAP) ≥20 mmHg combined with a pulmonary vascular resistance (PVR) ≥ 3 WU and pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg documented at right heart catheterization with radiographic evidence of organized thrombi involving the pulmonary arteries after 3 months of effective anticoagulation.
Exclusion
- Main cause of PH other than CTEPH
- Participation in a therapeutic clinical trial with an unknown drug;
- Withdrawal or lack of informed consent.
Key Trial Info
Start Date :
October 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05311072
Start Date
October 1 2015
End Date
December 31 2027
Last Update
January 23 2024
Active Locations (1)
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1
China-Japan Frendship hospital
Beijing, China, 100029