Database for chronic thromboembolic pulmonary hypertension in China
A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)
This study is creating a database to gather information on patients with chronic thromboembolic pulmonary hypertension in China to better understand the disease and improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05311072 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a multi-center disease registry for chronic thromboembolic pulmonary hypertension (CTEPH) patients across 18 centers in China. It will collect comprehensive data on the epidemiology, diagnosis, treatment options such as pulmonary endarterectomy and balloon pulmonary angioplasty, and long-term outcomes of CTEPH. The goal is to enhance understanding of the disease and improve management strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with chronic thromboembolic pulmonary hypertension who meet specific hemodynamic criteria.
Not a fit: Patients with pulmonary hypertension due to causes other than CTEPH or those currently participating in other therapeutic clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients with chronic thromboembolic pulmonary hypertension.
How similar studies have performed: Other studies have successfully utilized disease registries to improve understanding and management of chronic conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- China-Japan Frendship hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhenguo Zhai, Ph.D.
- Email: zhaizhenguo2011@126.com
- Phone: +86 10 84206269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.