Balloon Pulmonary Angioplasty for Adults with Chronic Thromboembolic Disease Without or Mild Pulmonary Hypertension Randomized Study on Quality of Life and Exercise Capacity

What this Trial Is About

Researchers are evaluating the effects of Balloon Pulmonary Angioplasty BPA on quality of life and exercise capacity in patients with chronic thromboembolic pulmonary disease CTEPD who do not have pulmonary hypertension PH. This randomized clinical trial uses a cross-over design to compare BPA treatment against standard care without intervention. The study aims to understand how BPA impacts patient-reported quality of life and physical performance over time. Participants are randomly assigned to either receive BPA treatment immediately or continue with standard care initially. At baseline, all participants complete questionnaires and exercise tests. The intervention group receives BPA first, followed by evaluations at 6, 12, and 24 months. After 6 months, the control group also receives BPA, allowing all participants to eventually undergo treatment. The study is open-label, but the primary outcome assessment is blinded. During the study, patients will complete quality of life questionnaires and undergo cardiopulmonary exercise testing at baseline and several follow-up points. Additional assessments include blood tests, imaging, and functional tests as part of clinical care before enrollment. Patient outcomes are measured at 6, 12, and 24 months, focusing on exercise capacity changes and disease-specific quality of life. The total follow-up period for participants is 24 months, with ongoing monitoring of symptoms and physical performance.

BPA in CTEPD Without PH