Actively Recruiting
Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
Led by Suqiao Yang · Updated on 2025-04-30
68
Participants Needed
3
Research Sites
136 weeks
Total Duration
On this page
Sponsors
S
Suqiao Yang
Lead Sponsor
C
China-Japan Friendship Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) with one of: pulmonary endarterectomy not possible, poor risk-benefit for endarterectomy, or residual/recurrent pulmonary hypertension after endarterectomy
- Treated with balloon pulmonary angioplasty (BPA) and stable riociguat dose for at least 12 weeks
- Mean pulmonary arterial pressure (mPAP) less than 30 mmHg
- Male and female subjects of reproductive age use effective contraception for at least 28 days after consent
- Voluntarily signed written informed consent
You will not qualify if you...
- Severe liver or kidney failure (Child-Pugh Grade C or creatinine clearance less than 30 ml/min/1.73m²)
- Severe infection or bleeding tendency
- Pulmonary hypertension caused by other types than CTEPH
- Use of other pulmonary hypertension targeting drugs
- Expected survival less than 6 months due to cancer or other diseases
- Pregnancy or breastfeeding
- Currently participating in another interventional clinical trial
- Medical conditions or history that may affect ability to participate or complete the study
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Chao-Yang Hospital
Beijing, China, China, 100020
Actively Recruiting
2
China-Japan Friendship Hospital
Beijing, China, China, 100029
Actively Recruiting
3
Beijing Anzhen Hospital
Beijing, China, China, 101118
Actively Recruiting
Research Team
S
Suqiao Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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