Switching of Sildenafil to Riociguat in CTEPH Patients

Recruiting now · Phase 4

Conditions studied: Chronic Thromboembolic Pulmonary Hypertension

In brief

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.

Key facts

Study ID: NCT06715280
Run by: Chinese University of Hong Kong
People needed: 30
Starts: 2024-07-25
Expected to finish: 2027-01-22
Last updated by the study team: 2025-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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