Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06715280

Switching of Sildenafil to Riociguat in CTEPH Patients

Led by Chinese University of Hong Kong · Updated on 2025-05-29

30

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Switching of Sildenafil to Riociguat in CTEPH Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

D

Daniel Xu Nurse

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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