Database for chronic thromboembolic pulmonary hypertension in China
Official title: A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)
Run by China-Japan Friendship Hospital · NCT05311072 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | October 1, 2015 |
| Main results expected | February 28, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | January 23, 2024 |
| Trial ID | NCT05311072 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with chronic thromboembolic pulmonary hypertension who meet specific hemodynamic criteria.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have successfully utilized disease registries to improve understanding and management of chronic conditions, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
-
China-Japan Frendship hospital
Beijing, China Recruiting
Study contacts
- Study coordinator: Zhenguo Zhai, Ph.D.
- Email: zhaizhenguo2011@126.com
- Phone: +86 10 84206269
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pulmonary Embolism Registry from Emergency Care to Long-Term Follow-Up
This registry follows adults with acute pulmonary embolism to see how care is given in the real world and what happens over time.
-
Nailfold Capillaroscopy in Pulmonary Hypertension
This study tests whether nailfold capillary scans correlate with invasive lung blood pressure measurements and whether these patterns change with PH treatment.
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How pulmonary endarterectomy affects confidence in managing chronic thromboembolic pulmonary hypertension
This project will see if pulmonary endarterectomy helps people with chronic thromboembolic pulmonary hypertension feel more confident managing their condition.
-
Registry of people with chronic thromboembolic pulmonary hypertension in Russia
This registry collects health, history, and treatment information from people in Russia with chronic thromboembolic pulmonary hypertension to see which factors relate to their prognosis.
-
Effects of stopping riociguat on heart function in patients with CTEPH
This study is testing how stopping the medication riociguat affects heart function in patients with inoperable CTEPH who have had balloon pulmonary angioplasty.
-
Switching from Sildenafil to Riociguat for CTEPH Patients
This study is testing if switching from sildenafil to riociguat can help people with Chronic Thromboembolic Pulmonary Hypertension feel better after they’ve already had balloon pulmonary angioplasty.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.