NCT06922240

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Suqiao Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Thromboembolic Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Riociguat	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.
DRUG	Routine Treatment	On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat

Timeline

• Start date: 2025-03-21
• Primary completion: 2026-10-30
• Completion: 2027-10-31
• First posted: 2025-04-10
• Last updated: 2025-04-30

Locations

3 sites across 1 country: China