Clinical Trials

BPA vs. PEA in CTEPH

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 79 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05110066
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Aarhus
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Irene Lang, MD,ProfHarm Jan Bogaard, MD, Prof.Marion Delcroix, MD, Prof.Marco Post, MD, Prof.Gregely Meszaros, MDJohanna Pepke-Zaba, MD, Prof.Christoph Wiedenroth, MD
Principal Investigator Affiliation	Medical University of ViennaAmsterdam University Medical CenterKU LeuvenSt. Antonius HospitalPulmonary Hypertension Association EuropePapworth Hospital NHS Foundation TrustKerckhoff Klinik
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Denmark, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Thromboembolic Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: BPA group

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.

Active Comparator: PEA group

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.

Interventions

Procedure: - Pulmonary endarterectomy

Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.

Procedure: - Balloon pulmonary angioplasty

Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.

Contact a Trial Team

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