NCT06922240RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 23 Mar 2025
- Start date
- 21 Mar 2025
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- Suqiao Yang
- NCT number
- NCT06922240
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 68
- From 21 Mar 2025 to the primary completion date, 30 Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Lab values
- Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance \< 30ml/min·1.73m²)
Other
- Pregnancy, lactation
- Subjects are currently participating in an interventional clinical trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Chao-Yang Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.