Effects of stopping riociguat on heart function in patients with CTEPH
Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy
This study is testing how stopping the medication riociguat affects heart function in patients with inoperable CTEPH who have had balloon pulmonary angioplasty.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital Academic / other |
| Locations | 3 sites (Beijing, China and 2 other locations) |
| Trial ID | NCT06922240 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of discontinuing riociguat on right heart function in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who have undergone balloon pulmonary angioplasty (BPA). The study aims to evaluate hemodynamic changes and right ventricular remodeling using advanced imaging techniques, including cardiac magnetic resonance and echocardiography. By assessing these effects, the trial seeks to clarify the optimal management strategy for patients who have achieved stability with BPA. Participants will undergo right heart catheterization to measure the hemodynamic impact of stopping riociguat after a stable treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with inoperable CTEPH who have been treated with BPA and stable riociguat for at least 12 weeks.
Not a fit: Patients with severe hepatic or renal insufficiency, or those with other types of pulmonary hypertension, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term management of CTEPH, potentially improving patient outcomes and treatment strategies.
How similar studies have performed: While the approach of evaluating the effects of medication discontinuation in CTEPH is not widely tested, similar studies have shown promising results in understanding treatment impacts in pulmonary hypertension.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, China and 2 other locations
- Beijing Chao-Yang Hospital — Beijing, China, China (Recruiting)
- China-Japan Friendship Hospital — Beijing, China, China (Recruiting)
- Beijing Anzhen Hospital — Beijing, China, China (Recruiting)
Study contacts
- Study coordinator: Suqiao Yang
- Email: yangsuqiao@126.com
- Phone: 010-85231217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.