Switching of Sildenafil to Riociguat in CTEPH Patients
Switching Sildenafil to Riociguat in Chronic Thromboembolic Pulmonary Hypertension After Balloon Pulmonary Angioplasty
Chinese University of Hong Kong
30 participants
Jul 25, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria5
- Previous treatment with riociguat other sGCs, or documented severe drug reaction or intolerance to sGCs
- 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
- Renal impairment with glomerular filtration rate \<15mL /min
- Child-Pugh C hepatic impairment
Interventions
Oral riociguat administered according to established dose-adjustment scheme. Riociguat will be administered starting at at 1mg three times per day. If patient systolic blood pressure maintains at 95mmHg or higher, the dose will be increased 0.5mg every 2 weeks up to a maximum dose 2.5mg three times per day over 8-week period
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06715280