BPA vs. PEA in CTEPH

Last updated: April 26, 2024
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Vascular Diseases

Circulation Disorders

Treatment

Pulmonary endarterectomy

Balloon pulmonary angioplasty

Clinical Study ID

NCT05110066
190580-0002
  • Ages 18-79
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Diagnosed with chronic thromboembolic pulmonary hypertension according to currentEuropean society of cardiology/European Respiratory Society guidelines and eligiblefor both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at thelocal 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 studyperiod

Exclusion

Exclusion Criteria:

  • Life expectancy <12 months
  • Co morbidities evaluated at the multidisciplinary team conference, that contributessignificantly to the patients pulmonary hypertension
  • Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomywithin 4 months after randomization.
  • Evaluated at multidisciplinary team conference that changes in pulmonary arteryhypertension targeted therapy between baseline and 4 months follow-up is inevitable*
  • Known pregnancy or positive urine Human chorionic gonadotropin screening test infertile women
  • Previous balloon pulmonary angioplasty or pulmonary endarterectomy

Study Design

Total Participants: 139
Treatment Group(s): 2
Primary Treatment: Pulmonary endarterectomy
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
April 01, 2028

Study Description

An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee.

PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session.

Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.

Connect with a study center

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Royal Ppworth

    Cambridge,
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.