Clinical trial NCT05110066: BPA vs. PEA in CTEPH
Official title: Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Kerckhoff Klinik
name: Medical University of Vienna
name: Papworth Hospital NHS Foundation Trust
name: St. Antonius Hospital
name: Utrecht University
name: KU Leuven
name: Amsterdam UMC, location VUmc
First posted: 2021-11-05
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pulmonary vascular resistance
timeFrame: 4 months and 12 months
Secondary outcomes:
measure: Mean pulmonary artery pressure
timeFrame: 4 months and 12 months
measure: Cardiac index
timeFrame: 4 months and 12 months
measure: Mean right atrial pressure
timeFrame: 4 months and 12 months
measure: Six minutes walking distance
timeFrame: 4 months and 12 months
measure: Time to clinical worsening
timeFrame: 4 months and 12 months
measure: N-terminal pro B-type natriuretic peptide
timeFrame: 4 months and 12 months
measure: Quality of life evaluated by the "Living with pulmonary hypertension questionnaire"
timeFrame: 4 months and 12 months
Other outcomes:
measure: Peri-operative/peri-interventional complications
timeFrame: 30 days
measure: Total length of hospital stay in both groups
timeFrame: 4 month
measure: Median survival at 12 month
timeFrame: 12 months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Cambridge
country: United Kingdom
facility: Royal Ppworth
Study officials:
affiliation: Medical University of Vienna
name: Irene Lang, MD,Prof
role: STUDY_CHAIR
affiliation: Amsterdam University Medical Center
name: Harm Jan Bogaard, MD, Prof.
role: STUDY_CHAIR
affiliation: KU Leuven
name: Marion Delcroix, MD, Prof.
role: STUDY_CHAIR
affiliation: St. Antonius Hospital
name: Marco Post, MD, Prof.
role: STUDY_CHAIR
affiliation: Pulmonary Hypertension Association Europe
name: Gregely Meszaros, MD
role: STUDY_CHAIR
affiliation: Papworth Hospital NHS Foundation Trust
name: Johanna Pepke-Zaba, MD, Prof.
role: STUDY_CHAIR
affiliation: Kerckhoff Klinik
name: Christoph Wiedenroth, MD
role: STUDY_CHAIR
References:
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