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NCT06922240: RED-HEART

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

Recruiting now Phase 3 Last updated 30 April 2025
What this trial tests

Phase 3 trial testing Riociguat in Chronic Thromboembolic Pulmonary Hypertension in 68 participants. Currently enrolling.

Timeline
21 March 2025
Primary endpoint
30 October 2026
31 October 2027

Quick facts

Lead sponsorSuqiao Yang
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment68
Start date21 March 2025
Primary completion30 October 2026
Estimated completion31 October 2027
Sites3 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Suqiao Yang

Who can join

18 and older, any sex, with Chronic Thromboembolic Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Riociguat

Trials testing the same drug.

Other recruiting trials for Chronic Thromboembolic Pulmonary Hypertension

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

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