BPA vs. PEA in CTEPH

ConditionChronic Thromboembolic Pulmonary Hypertension

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Pulmonary endarterectomy
Procedure/Surgery
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
Balloon pulmonary angioplasty
Procedure/Surgery
Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.

Treatment groups

139 Participants

are divided into 2 treatment groups

Group A: BPA groupActive comparator 1 intervention

Group B: PEA groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in pulmonary vascular resistance

Change in pulmonary vascular resistance from baseline to 4-months and 12-months after the procedure(s). Patients on medical treatments at baseline will remain on medical treatments until the assessment of the primary endpoint, and be taken off if hemodynamics permit

Time frame

4 months and 12 months

Secondary outcomes

Mean pulmonary artery pressure

Mean pulmonary artery pressure measured by right heart catheterization

Time frame

4 months and 12 months

Cardiac index

Cardiac index measured by right heart catheterization

Time frame

4 months and 12 months

Mean right atrial pressure

Right atrial pressure measured by right heart catheterization

Time frame

4 months and 12 months

Six minutes walking distance

Time frame

4 months and 12 months

Other outcomes

Peri-operative/peri-interventional complications

Complications related to balloon pulmonary angioplasty and pulmonary endarterectomy will be recorded

Time frame

30 days

Total length of hospital stay in both groups

Time of hospital stay will be recorded

Time frame

4 month

Median survival at 12 month

Deaths will be recorded recorded and a median 12 month survival will be calculated.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

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