BPA vs. PEA in CTEPH

Launched by UNIVERSITY OF AARHUS · Oct 27, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two treatments for a serious condition called chronic thromboembolic pulmonary hypertension (CTEPH), which can happen when blood clots in the lungs do not resolve properly. The standard treatment is a surgical procedure called pulmonary endarterectomy (PEA), but not everyone can have this surgery. Some patients might be better suited for a different treatment called balloon pulmonary angioplasty (BPA). This study aims to find out if BPA is just as effective as PEA for patients who can choose between the two treatments.

To participate in this trial, you must be between 18 and 80 years old and have been diagnosed with CTEPH. You also need to be eligible for both BPA and PEA, as determined by a team of medical experts. Participants will receive either BPA or PEA, and the study will monitor their health over time. It's important to note that if you have a serious other illness, are pregnant, or have had one of these procedures before, you may not qualify for this trial. Overall, this study will help doctors understand which treatment option is best for patients with CTEPH.

Gender

ALL

Eligibility 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