Comparing balloon pulmonary angioplasty and pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension
Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
This study is testing whether a new procedure called balloon pulmonary angioplasty works better than the traditional surgery for people with chronic thromboembolic pulmonary hypertension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 139 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Trial ID | NCT05110066 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of balloon pulmonary angioplasty (BPA) compared to pulmonary endarterectomy (PEA) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are eligible for both treatments. It is a multicenter, prospective, randomized, controlled, open-label trial involving 152 patients. Participants will be randomly assigned to receive either BPA or PEA, with follow-up assessments including right heart catheterization at 4 and 12 months post-treatment. The primary endpoint is the change in pulmonary vascular resistance from baseline to these follow-up points.
Who should consider this trial
Good fit: Ideal candidates are patients aged 17 to 80 diagnosed with CTEPH who are eligible for both BPA and PEA.
Not a fit: Patients with a life expectancy of less than 12 months or significant comorbidities affecting their pulmonary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with CTEPH who are eligible for both BPA and PEA.
How similar studies have performed: While BPA has shown promise in treating CTEPH, this study represents a novel head-to-head comparison with PEA, which has not been previously conducted.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee * Written informed consent from the patient * Patient age \>17 and \<80 years * Able to understand and follow instructions and to participate in the entire study period Exclusion Criteria: * Life expectancy \<12 months * Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension * Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization. * Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\* * Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women * Previous balloon pulmonary angioplasty or pulmonary endarterectomy
Where this trial is running
Aarhus and 1 other locations
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Royal Ppworth — Cambridge, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Asger Andersen, MD, ass.prof.
- Email: asger.andersen@clin.au.dk
- Phone: 40138052
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.