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

Study acronym: RED-HEART
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 4 to Phase 3 Trial status: Active, Not Recruiting to Recruiting · Study sites: 1 to 3 · Interventions: routine treatment and oral riociguat (Drug) to Riociguat (Drug), Routine Treatment (Drug)v2 Show 3 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 1 to 3
    • Interventions: routine treatment and oral riociguat (Drug) to Riociguat (Drug), Routine Treatment (Drug)
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Suqiao Yang
1 trial monitored
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Hypertension
1,795 trials monitored
See 85 trials at risk
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.
Trial Details
NCT Number NCT06922240
Lead Sponsor Suqiao Yang
Collaborators: China-Japan Friendship Hospital, Beijing Anzhen Hospital
Conditions Chronic Thromboembolic Pulmonary Hypertension
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov