Study of Combined Riociguat and Macitentan Therapy Followed by Balloon Pulmonary Angioplasty to Improve Heart and Lung Function in Chronic Thromboembolic Pulmonary Hypertension

What this Trial Is About

Researchers are studying the effects of combining two medications, Riociguat and Macitentan, followed by balloon pulmonary angioplasty BPA on heart function and blood flow in people with chronic thromboembolic pulmonary hypertension CTEPH who cannot have surgery or have remaining disease after surgery. The study focuses on how these treatments improve the hearts right ventricle and its connection to the lungs blood vessels. This is a Phase 3 clinical trial led by Dr. Sudarshan Rajagopal. Participants will first receive combination medical therapy with Macitentan tablets taken once daily and Riociguat taken three times daily, followed by BPA, a procedure to open blocked lung arteries. The study compares two groups those with inoperable CTEPH and those with residual disease after pulmonary endarterectomy PTE. Treatments and effects will be monitored over time, including before treatment, after up to six months of medical therapy, and after up to twelve months following BPA. During the study, participants will undergo measurements including invasive heart catheterization to assess heart and lung blood flow function, six-minute walk tests, and blood tests for heart stress markers. These assessments will happen at baseline, after medical therapy, and after BPA. The study includes monitoring of hemodynamics, right ventricular-pulmonary artery coupling, and other heart and lung function indicators throughout the study period.

Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH