RecruitingPhase 3NCT05140525

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


Sponsor

Dr Sudarshan Rajagopal

Enrollment

15 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how starting drug therapy followed by a minimally invasive lung procedure (balloon pulmonary angioplasty/BPA) affects heart function in people with chronic thromboembolic pulmonary hypertension (CTEPH) — a type of high blood pressure in the lungs caused by old blood clots. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CTEPH - You are not a candidate for surgical clot removal (pulmonary thromboendarterectomy) - You are suitable for balloon pulmonary angioplasty (BPA) - You have not yet started any CTEPH/PAH-specific medication **You may NOT be eligible if...** - You are already on CTEPH or pulmonary hypertension medications - You are a candidate for surgical removal of the clots - You are not suitable for BPA based on anatomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMacitentan Tablets

10 mg oral once daily

DRUGRiociguat

1 mg to 2.5mg oral three times daily

DEVICEballoon pulmonary angioplasty

on hemodynamics and RV function (including advanced assessments of RV-PA coupling


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT05140525


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