Actively Recruiting
BPA vs. PEA in CTEPH
Led by University of Aarhus · Updated on 2024-04-29
139
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
K
Kerckhoff Klinik
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
BPA vs. PEA in CTEPH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines
- Eligible for both pulmonary endarterectomy and balloon pulmonary angioplasty as decided by local multidisciplinary team and central adjudication committee
- Written informed consent provided
- Age greater than 17 years and less than 80 years
- Able to understand and follow instructions and participate throughout the study period
You will not qualify if you...
- Life expectancy less than 12 months
- Co-morbidities significantly contributing to pulmonary hypertension as evaluated by the multidisciplinary team
- Unable to undergo balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization
- Changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up are considered inevitable by the multidisciplinary team
- Known pregnancy or positive urine human chorionic gonadotropin test in fertile women
- Previous balloon pulmonary angioplasty or pulmonary endarterectomy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Royal Ppworth
Cambridge, United Kingdom
Actively Recruiting
Research Team
A
Asger Andersen, MD, ass.prof.
CONTACT
K
Kristina Laut Matzen, RN,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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