Switching of Sildenafil to Riociguat in CTEPH Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Riociguat (Adempas)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov