Switching of Sildenafil to Riociguat in CTEPH Patients

Launched by CHINESE UNIVERSITY OF HONG KONG · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether switching from sildenafil, a common medication for Chronic Thromboembolic Pulmonary Hypertension (CTEPH), to a different drug called riociguat can help patients who still have symptoms after undergoing a procedure called Balloon Pulmonary Angioplasty (BPA). The goal is to see if this change in medication is safe and effective for patients who have been on a stable dose of sildenafil for at least six weeks but are still experiencing issues related to their condition.

To participate in the trial, you need to have a confirmed diagnosis of CTEPH, feel symptoms after your BPA, and currently be taking sildenafil. You should also be classified as having a moderate level of functional impairment (WHO functional class III). Participants will be monitored closely throughout the study to assess the effects of the new medication. It’s important to note that certain individuals, such as those who have recently been hospitalized for heart-related issues or have severe kidney or liver problems, may not be eligible for this trial. This study is currently looking for volunteers, so if you think you might qualify, it could be a great opportunity to help advance treatment options for CTEPH.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with established diagnosis of CTEPH who are symptomatic after Balloon pulmonary angioplasty (BPA)
• • 2. 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
• • 3. WHO functional class III at screening
• • 4. Stable dose of diuretics (if used) for at least 30 days at screening
• • 5. No recent hospitalisation due to pulmonary hypertension or heart failure for at least 30 days
• Exclusion Criteria:
• • 1. Previous treatment with riociguat other sGCs, or documented severe drug reaction or intolerance to sGCs
• • 2. Use of nitrates or nitric oxide donors (eg, nitroglycerin, amyl nitrite, isosorbide dinitrate etc) by any administration routes within 30 days of screening
• • 3. Pregnant women or breast-feeding women, or women with childbearing potential not using of combination of two effective contraception methods throughout study
• • 4. Renal impairment with glomerular filtration rate \<15mL /min
• • 5. Child-Pugh C hepatic impairment