NCT05140525

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

Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Dr Sudarshan Rajagopal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

Detailed description

Recent presented but unpublished results from trials of BPA vs riociguat for inoperable CTEPH (NCT02634203) have demonstrated that BPA provides a more significant hemodynamic benefit than medical therapy. The investigators hypothesize that participants who are treated with upfront combination medical therapy followed by BPA will have significant improvements in their hemodynamics and RV-PA coupling that can be monitored over time.

Conditions

• CTEPH

Interventions

Type	Name	Description
DRUG	Macitentan Tablets	10 mg oral once daily
DRUG	Riociguat	1 mg to 2.5mg oral three times daily
DEVICE	balloon pulmonary angioplasty	on hemodynamics and RV function (including advanced assessments of RV-PA coupling

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-12-01
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study