Comparing balloon pulmonary angioplasty and pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of people with chronic thromboembolic pulmonary hypertension in Russia

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• Effects of stopping riociguat on heart function in patients with CTEPH

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• 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.

  Recruiting Phase 4 Chinese University of Hong Kong · Hong Kong · NCT06715280

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.