Switching from Sildenafil to Riociguat for CTEPH Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of replacing phosphodiesterase 5 inhibitors (PDE5i) with riociguat in patients suffering from Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who remain symptomatic after undergoing balloon pulmonary angioplasty (BPA). The trial aims to determine if riociguat can provide better outcomes for these patients compared to continued treatment with PDE5i. It focuses on patients who have been on a stable dose of sildenafil for at least six weeks and are classified as WHO functional class III. The study is crucial as it addresses a significant gap in treatment options for those with inoperable CTEPH.

Why it matters

Who can join: the full rules

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

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Daniel Xu Nurse
• Email: danielxu@cuhk.edu.hk
• Phone: +85235051518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulmonary Embolism Registry from Emergency Care to Long-Term Follow-Up

  This registry follows adults with acute pulmonary embolism to see how care is given in the real world and what happens over time.

  Recruiting at 16 sites Azienda Ospedaliero-Universitaria Careggi · Bagno a Ripoli, Tuscany and 15 other locations · NCT07855679

• Nailfold Capillaroscopy in Pulmonary Hypertension

  This study tests whether nailfold capillary scans correlate with invasive lung blood pressure measurements and whether these patterns change with PH treatment.

  Recruiting University of Glasgow · Clydebank, West Dunbartonshire · NCT07768644

• How pulmonary endarterectomy affects confidence in managing chronic thromboembolic pulmonary hypertension

  This project will see if pulmonary endarterectomy helps people with chronic thromboembolic pulmonary hypertension feel more confident managing their condition.

  Recruiting Damascus University · Damascus, Rif-dimashq Governorate · NCT07272798

• Registry of people with chronic thromboembolic pulmonary hypertension in Russia

  This registry collects health, history, and treatment information from people in Russia with chronic thromboembolic pulmonary hypertension to see which factors relate to their prognosis.

  Recruiting National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Moscow · NCT07254078

• Effects of stopping riociguat on heart function in patients with CTEPH

  This study is testing how stopping the medication riociguat affects heart function in patients with inoperable CTEPH who have had balloon pulmonary angioplasty.

  Recruiting at 3 sites Phase 3 Beijing Chao Yang Hospital · Beijing, China and 2 other locations · NCT06922240

• Using AI to improve imaging for pulmonary embolism diagnosis

  This study is testing if using advanced imaging and artificial intelligence can help doctors diagnose and manage pulmonary embolism better for patients who might have it.

  Recruiting China-Japan Friendship Hospital · Beijing · NCT06526468

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.