NCT06922240 Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
| NCT ID | NCT06922240 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suqiao Yang |
| Condition | Chronic Thromboembolic Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 68 participants in total. It began in 2025-03-21 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Age ≥18 years old * CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is technically feasible, but the risk-benefit ratio is poor; Residual/recurrent pulmonary hypertension after pulmonary endarterectomy * Subjects had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks * mPAP \< 30mmHg * Male subjects and female subjects of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent form. Male subjects are not allowed to donate sperm and female subjects are not allowed to breastfeed. * Subjects voluntarily sign written informed consent Exclusion Criteria: * Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance \< 30ml/min·1.73m²) * The presence of severe infectious disease or severe bleeding tendency * Combined with pulmonary hypertension of other types than CTEPH * Other pulmonary hypertension targeting drugs are being used * The expected survival time with cancer or other diseases is less than 6 months * Pregnancy, lactation * Subjects are currently participating in an interventional clinical trial * In the investigator's judgment, a subject's medical abnormality, physical condition, or medical history may affect his or her ability to participate in or complete the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06922240 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Thromboembolic Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06922240 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 68 participants.
Is NCT06922240 currently recruiting?
Yes, NCT06922240 is actively recruiting participants. Contact the research team at yangsuqiao@126.com for enrollment information.
Where is the NCT06922240 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China.
Who is sponsoring the NCT06922240 clinical trial?
NCT06922240 is sponsored by Suqiao Yang. The trial plans to enroll 68 participants.