BPA vs. PEA in CTEPH
Recruiting · NCT05110066 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons. Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
Who can take part
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 is running
2 locations listed.
- Aarhus University Hospital - Aarhus, Denmark
- Royal Ppworth - Cambridge, United Kingdom