RecruitingPhase 4NCT06715280

Switching of Sildenafil to Riociguat in CTEPH Patients

Switching Sildenafil to Riociguat in Chronic Thromboembolic Pulmonary Hypertension After Balloon Pulmonary Angioplasty


Sponsor

Chinese University of Hong Kong

Enrollment

30 participants

Start Date

Jul 25, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether switching from sildenafil (a common pulmonary hypertension medication) to riociguat can improve outcomes in patients with chronic thromboembolic pulmonary hypertension (CTEPH) — a type of high blood pressure in the lungs caused by old blood clots — who remain symptomatic after balloon pulmonary angioplasty (a procedure to open blocked lung arteries). **You may be eligible if...** - You have confirmed CTEPH with ongoing symptoms after balloon pulmonary angioplasty - You are currently taking sildenafil at a stable maximum tolerated dose for at least 6 weeks - You are in WHO functional class III (moderate-severe symptoms limiting activity) - You have not been hospitalized for pulmonary hypertension or heart failure in the past 30 days **You may NOT be eligible if...** - You have previously taken riociguat or similar drugs (soluble guanylate cyclase stimulators) - You are taking nitrates (e.g., nitroglycerin) or nitric oxide donors - You are pregnant or breastfeeding, or not using effective contraception - You have severely reduced kidney function - You have severe liver impairment (Child-Pugh C) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRiociguat (Adempas)

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)

Prince of Wales Hospital

Hong Kong, Hong Kong

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NCT06715280


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