NCT06715280 Switching of Sildenafil to Riociguat in CTEPH Patients
| NCT ID | NCT06715280 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Chronic Thromboembolic Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-25 |
| Primary Completion | 2026-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2024-07-25 with a primary completion date of 2026-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study was designed to investigate the safety and efficacy of replacing phosphodiesterase 5 inhibitors (PDE5i) with riociguat in patients with Chronic thromboembolic pulmonary hypertension (CTEPH) who have undergone pulmonary angioplasty (BPA) and remains symptomatic despite treatments with PDE5i.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06715280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Thromboembolic Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06715280 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06715280 currently recruiting?
Yes, NCT06715280 is actively recruiting participants. Contact the research team at danielxu@cuhk.edu.hk for enrollment information.
Where is the NCT06715280 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06715280 clinical trial?
NCT06715280 is sponsored by Chinese University of Hong Kong. The trial plans to enroll 30 participants.