Switching sildenafil to riociguat in chronic clot-related lung blood pressure disease
Tests switching from sildenafil to riociguat in adults with chronic thromboembolic pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: Switching of Sildenafil to Riociguat in CTEPH Patients
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 4
Where in Hong Kong
- Prince of Wales HospitalHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT06715280
- Record updated
- 29 May 2025
- Original description
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.Read full original descriptionShow less
Switching Sildenafil to Riociguat in Chronic Thromboembolic Pulmonary Hypertension After Balloon Pulmonary Angioplasty
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.
Inclusion: Patients with established diagnosis of CTEPH who are symptomatic after Balloon pulmonary angioplasty (BPA); 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; WHO functional class III at screening; Stable dose of diuretics (if used) for at least 30 days at screening; No recent hospitalisation due to pulmonary hypertension or heart failure for at least 30 days.
Exclusion: Previous treatment with riociguat other sGCs, or documented severe drug reaction or intolerance to sGCs; Renal impairment with glomerular filtration rate <15mL /min; Child-Pugh C hepatic impairment; Use of nitrates or nitric oxide donors (eg, nitroglycerin, amyl nitrite, isosorbide dinitrate etc) by any administration routes within 30 days of screening; Pregnant women or breast-feeding women, or women with childbearing potential not using of combination of two effective contraception methods throughout study.