Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients
Study Purpose
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.
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 and Over |
Gender | All |
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. |
NCT02964390 |
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. |
Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Marcin Kurzyna, MD,PhD |
Principal Investigator Affiliation | European Health Center Otwock |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Poland |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Chronic Thromboembolic Pulmonary Hypertension |
Contact a Trial Team
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