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Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
NCT05311072 · China-Japan Friendship Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)
About this study
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 prognosis of CTEPH will be evaluated.
Eligibility criteria
Inclusion Criteria:
1. Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
2. Patients must be willing to provide informed consent
3. 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 Criteria:
1. Main cause of PH other than CTEPH
2. Participation in a therapeutic clinical trial with an unknown drug;
3. Withdrawal or lack of informed consent.
Study design
Enrollment target: 1500 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2015-10-01
Estimated completion: 2027-12-31
Last updated: 2024-01-23
Interventions
Procedure: pulmonary endarterectomy or balloon pulmonary angioplasty
Primary outcomes
- • death (3 years)
- • The change in mean pulmonary artery pressure (mPAP) in millimetre of mercury (mmHg), pulmonary vascular resistance (PVR) in Wood units, cardiac output (CO) in liter per minute (L/min) or cardiac index (CI) in liter per minute (L/min). (3 years)
- • The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter（pg/ml), or WHO-functional class. (3 years)
Sponsor
China-Japan Friendship Hospital · other
Contacts & investigators
ContactZhenguo Zhai, Ph.D. · contact · zhaizhenguo2011@126.com · +86 10 84206269
All locations (1)
China-Japan Frendship hospitalRecruiting
Beijing, China