RecruitingPhase 3NCT06922240

Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy


Sponsor

Suqiao Yang

Enrollment

68 participants

Start Date

Mar 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Specifically, there is no consensus on whether riociguat should be continued long-term after achieving hemodynamic stability with BPA. Additionally, the long-term effects of riociguat discontinuation on right ventricular (RV) structure and function remain poorly characterized, particularly due to the lack of comprehensive noninvasive evaluations integrating cardiac magnetic resonance (CMR) and echocardiography. This prospective study aims to determine the hemodynamic impact of riociguat discontinuation in inoperable CTEPH patients who have achieved BPA treatment endpoints using right heart catheterization (RHC). Evaluate RV remodeling and functional changes after riociguat cessation through multimodal noninvasive imaging (CMR, echocardiography). Assess safety outcomes and identify potential rebound pulmonary hypertension or decompensated RV dysfunction associated with riociguat withdrawal.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether it is safe to stop or reduce the drug riociguat in patients with chronic thromboembolic pulmonary hypertension (CTEPH — a condition where old blood clots block arteries in the lungs, causing high lung blood pressure) who have responded well to a procedure called balloon pulmonary angioplasty (BPA). **You may be eligible if...** - You are 18 or older - You have CTEPH that was not fully treatable with surgery, or you still have elevated lung pressure after surgery - You have completed BPA treatment and have been on a stable dose of riociguat for at least 12 weeks - Your mean pulmonary arterial pressure is now less than 30 mmHg (improved) **You may NOT be eligible if...** - You have severe liver or kidney disease - You are pregnant or breastfeeding - Your lung pressures are still significantly elevated - You are on medications that interact with riociguat 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

DRUGRiociguat

On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc., continue oral administration of riociguat for treatment.

DRUGRoutine Treatment

On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat


Locations(3)

Beijing Chao-Yang Hospital

Beijing, China, China

China-Japan Friendship Hospital

Beijing, China, China

Beijing Anzhen Hospital

Beijing, China, China

View Full Details on ClinicalTrials.gov

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NCT06922240


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