Status:
RECRUITING
Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
Lead Sponsor:
Suqiao Yang
Collaborating Sponsors:
China-Japan Friendship Hospital
Beijing Anzhen Hospital
Conditions:
Chronic Thromboembolic Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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. H...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06922240
Start Date
March 21 2025
End Date
October 31 2027
Last Update
April 30 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Chao-Yang Hospital
Beijing, China, China, 100020
2
China-Japan Friendship Hospital
Beijing, China, China, 100029
3
Beijing Anzhen Hospital
Beijing, China, China, 101118