BPA vs. PEA in CTEPH (GO-CTEPH)

University of Aarhus

Status: Enrolling

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: Balloon pulmonary angioplasty; Procedure: Pulmonary endarterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05110066

190580-0002

Details and patient eligibility

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.

Full 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.

Enrollment: 139 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups

BPA group

Active Comparator group

Description:

Balloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician.

Treatment:

Procedure: Balloon pulmonary angioplasty

PEA group

Active Comparator group

Description:

Patients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians.

Treatment:

Procedure: Pulmonary endarterectomy