BPA vs. PEA in CTEPH

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of Aarhus

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

139 Participants
are divided into 2 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