Switching from Sildenafil to Riociguat for CTEPH Patients
Switching Sildenafil to Riociguat in Chronic Thromboembolic Pulmonary Hypertension After Balloon Pulmonary Angioplasty
This study is testing if switching from sildenafil to riociguat can help people with Chronic Thromboembolic Pulmonary Hypertension feel better after they’ve already had balloon pulmonary angioplasty.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06715280 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of replacing phosphodiesterase 5 inhibitors (PDE5i) with riociguat in patients suffering from Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who remain symptomatic after undergoing balloon pulmonary angioplasty (BPA). The trial aims to determine if riociguat can provide better outcomes for these patients compared to continued treatment with PDE5i. It focuses on patients who have been on a stable dose of sildenafil for at least six weeks and are classified as WHO functional class III. The study is crucial as it addresses a significant gap in treatment options for those with inoperable CTEPH.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with CTEPH who are symptomatic after BPA and have been on a stable dose of sildenafil.
Not a fit: Patients who have previously been treated with riociguat or have severe drug reactions to soluble guanylate cyclase stimulators may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve symptoms and quality of life for patients with CTEPH who do not respond adequately to current treatments.
How similar studies have performed: Previous studies have shown that riociguat can significantly improve outcomes in patients with inoperable CTEPH, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with established diagnosis of CTEPH who are symptomatic after Balloon pulmonary angioplasty (BPA) 2. Patients who are on stable maximally tolerated dose of sildenafil for at least 6 weeks as monotherapy, or in combination with other pulmonary hypertension specific therapies 3. WHO functional class III at screening 4. Stable dose of diuretics (if used) for at least 30 days at screening 5. No recent hospitalisation due to pulmonary hypertension or heart failure for at least 30 days Exclusion Criteria: 1. Previous treatment with riociguat other sGCs, or documented severe drug reaction or intolerance to sGCs 2. Use of nitrates or nitric oxide donors (eg, nitroglycerin, amyl nitrite, isosorbide dinitrate etc) by any administration routes within 30 days of screening 3. Pregnant women or breast-feeding women, or women with childbearing potential not using of combination of two effective contraception methods throughout study 4. Renal impairment with glomerular filtration rate \<15mL /min 5. Child-Pugh C hepatic impairment
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Daniel Xu Nurse
- Email: danielxu@cuhk.edu.hk
- Phone: +85235051518
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.