About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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*
Trial design
Treatments tested in this trial
- Pulmonary endarterectomy
- Balloon pulmonary angioplasty
Treatment groups
Sponsors and collaborators
University of Aarhus
Lead sponsor
Kerckhoff Klinik
Collaborator
Medical University of Vienna
Collaborator
Papworth Hospital NHS Foundation Trust
Collaborator
St. Antonius Hospital
Collaborator
Utrecht University
Collaborator
KU Leuven
Collaborator
Amsterdam UMC, location VUmc
Collaborator