Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
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 riocigua
| Condition(s) | Chronic Thromboembolic Pulmonary Hypertension |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 patient |
| Who can participate | 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 insuffi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Suqiao Yang |
| Locations | Beijing, China, China; Beijing, China, China; Beijing, China, China |
| Start date | 2025-03-21 |
| NCT ID | NCT06922240 |
| Official listing | https://clinicaltrials.gov/study/NCT06922240 |