Evaluating balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension in China
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
This study is testing whether balloon pulmonary angioplasty can safely help people with chronic thromboembolic pulmonary hypertension who can't have surgery or still have symptoms after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese Pulmonary Vascular Disease Research Group Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT04206852 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of balloon pulmonary angioplasty (BPA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not suitable for pulmonary endarterectomy or have persistent CTEPH after the procedure. The study involves a multi-center approach, where clinical evaluations such as functional capacity tests, biomarkers, and imaging studies will be conducted before and after BPA treatment. Additionally, the study will explore the predictive value of FAPI in determining treatment efficacy and patient prognosis.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with CTEPH who are not amenable to pulmonary endarterectomy and have been on anticoagulation therapy for at least three months.
Not a fit: Patients who are unwilling or unable to provide consent or those who cannot be followed up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with CTEPH who currently have limited therapeutic alternatives.
How similar studies have performed: While balloon pulmonary angioplasty is a recognized treatment, this specific observational study is novel in its comprehensive evaluation of safety and efficacy in the Chinese population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines 2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH 3. Not amenable to pulmonary endarterectomy 4. Willing to provide informed consent Exclusion Criteria: 1. Patients unwilling or unable to provide written consent for participation in the study. 2. Impossible to follow up.
Where this trial is running
Beijing and 1 other locations
- center of pulmonary vascular disease, Fuwai hospital — Beijing, China (Recruiting)
- Chinese Academy of Medical Sciences Fuwai hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhihong Liu, doctor
- Email: zhihongliufuwai@163.com
- Phone: 86-010-88396589
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.