Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for
non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).
The aim of this study was to evaluate the safety and efficacy of BPA in patients disqualified
from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.
This is a interventional study analyzing the benefits and the risk of BPA. Clinical
evaluation, including: functional capacity, 6-minutes walking test, haemodynamics,
biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL
assessment with Short Form 36 (SF36) questionnaire was performed before the initiation
therapy of BPA, and 3-6 months after last session of BPA.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
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The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but potentially
life-threatening disease of the pulmonary circulation. Management of CTEPH requires precise
differential diagnosis, long life anticoagulation when confirmed and qualification for
surgical treatment by an experienced multidisciplinary team. The gold standard of treatment
in operable patients is pulmonary endarterectomy (PEA), which is highly effective in
restoring functional status and improving life expectancy. Nevertheless, even in the leading
CTEPH referral centres almost 50% patients remain on medical treatment alone, with grim
perspectives regarding life quality and expectancy. Recently, balloon pulmonary angioplasty
(BPA) has emerged as a promising new interventional option in non-operable CTEPH.
The development BPA was far from rapid. It took 13 years from the first case-report to the
publication of a first series of 17 patients treated with BPA in Boston/US and another 13
years until the results of first European series of 20 patients has been reported from
Oslo/Norway. In Poland BPA was started to perform in non-operable CTEPH patients in 2013,
motivated by their expected poor prognosis, when compared to those to whom surgical PEA was
The aim of this study is an analysis of efficacy and safety of BPA procedure.
The BPA is performed by two senior interventional specialist
Experimental: Balloon Pulmonary Angioplasty
This arm includes patients qualified to BPA procedure. They have a baseline workup performed before the initiation of BPA treatment and had a follow up examination from 3 to 6 months after the last BPA session.
Procedure: - Balloon Pulmonary Angioplasty
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
European Health Center Otwock
Otwock, , 05-400
Marcin Kurzyna, MD, PhD