Switching of Sildenafil to Riociguat in CTEPH Patients
Recruiting · NCT06715280 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
Riociguat (Adempas)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Prince of Wales Hospital - Hong Kong, Hong Kong