Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

Launched by SUQIAO YANG · Apr 9, 2025

Keywords

ClinConnect Summary

The RED-HEART trial is studying the effects of stopping a medication called riociguat in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who have already undergone balloon pulmonary angioplasty (BPA) treatment. Researchers want to understand how discontinuing riociguat affects heart function and structure, particularly the right side of the heart, after patients have achieved stable blood flow. This trial aims to gather important information on whether stopping riociguat is safe and if it leads to any worsening of heart function or blood pressure in the lungs.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with CTEPH. They should have undergone BPA treatment and been on a stable dose of riociguat for at least 12 weeks, with specific blood pressure levels in the lungs. Participants can expect to undergo tests that include heart imaging to evaluate changes after stopping the medication. It’s important to note that individuals with certain severe health conditions or those currently pregnant or breastfeeding are not eligible for this trial.

Gender

ALL

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