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NCT06715280RecruitingPhase 4

Switching of Sildenafil to Riociguat in CTEPH Patients

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

Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
30 (estimated)
First submitted
26 Nov 2024
Start date
25 Jul 2024
Primary completion date
22 Jul 2026
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT06715280

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 30
  • From 25 Jul 2024 to the primary completion date, 22 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with riociguat other sGCs, or documented severe drug reaction or intolerance to sGCs

Other illness

  • Renal impairment with glomerular filtration rate \<15mL /min
  • Child-Pugh C hepatic impairment

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Prince of Wales Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.