GO-CTEPH
Research type
Research Study
Full title
Balloon pulmonary anGiOplasty versus pulmonary endarterectomy in patients with Chronic ThromboEmbolic Pulmonary Hypertension: a non-inferiority randomized trial
IRAS ID
306373
Contact name
Joanna Pepke-Zaba
Contact email
Sponsor organisation
Aarhus University
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 28 days
Research summary
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that from unresolved pulmonary blood clots. Standard treatment for CTEPH is an operation called pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons to remove blockages. Some patients aren’t eligible for treatment due to co-morbidities or due to vascular blockages too far away from the main artery, making them technically inoperable. In these patients balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. BPA is a minimal invasive therapy that uses balloons to open chronically narrowed and blocked blood vessels. BPA is carried out from the groin using local anaesthesia. Often it will take several BPA procedures to open blocked arteries; meaning several hospital visits. The treatment depends on an evaluation of the individual’s risks, benefits, and location blockage. In some patients, the distribution of blockages makes it possible to perform either BPA or PEA. Today, PEA is the first-choice treatment for this sub-group of patients, however no study has compared whether BPA is equally effective. The aim of this project is to investigate whether treatment with balloon therapy (BPA) is as good as surgical removal of blockages (PEA) in CTEPH patients with chronic blood clots in the lungs. In this study 139 adults over the age of 18 up to 80 with CTEPH that are eligible for both balloon therapy and conventional surgery will be randomized 1: 1 for treatment with either traditional surgery (PEA) or balloon therapy (BPA). All participants will be assessed by expert medical professionals at the Hospital's Cardiology Dept. to assess whether a good treatment result can be achieved with both PEA and BPA. The trial is planned to be performed over 12 months and consists of screening and randomisation visits followed by a visit at 4 months and at 12 months.
REC name
London - Stanmore Research Ethics Committee
REC reference
22/LO/0871
Date of REC Opinion
3 Mar 2023
REC opinion
Further Information Favourable Opinion