Switching of Sildenafil to Riociguat in CTEPH Patients

NCT06715280 | Recruiting Phase 4 DMC

• 1 other identifier: 2023.577
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

CTEPH; BPA; Riociguat; Sildenafil

Outcome Measures

Primary Outcomes (2)

• Change in mean pulmonary artery pressure (mPAP)

  Change in mean pulmonary artery pressure (mPAP) measured in right heart catheterization at baseline and at week 26. Pulmonary hypertension (PH) is defined as pulmonary artery pressure (PAP) ≥ 25 mmHg. And the normal resting PAP is 8-20 mmHg.

  26 weeks

• Change in pulmonary vascular resistance (PVR)

  Change in pulmonary vascular resistance (PVR) measured in right heart catheterization at baseline and at week 26. Pulmonary vascular resistance (PVR) is similar to systemic vascular resistance (SVR) except it refers to the arteries that supply blood to the lungs.

  26 weeks

Secondary Outcomes (10)

• Change in cardiac output (CO)

  26 weeks

• Change in cardiac index (CI)

  26 weeks

• Change in pulmonary artery wedge pressure (PAWP)

  26 weeks

• Change in The World Health Organization (WHO) functional class

  26 weeks

• Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) level

  26 weeks

Study Arms (1)

Patients with Chronic Thromboembolic Pulmonary Hypertension

OTHER

Patients with Chronic Thromboembolic Pulmonary Hypertension under Sildenafil treatment

Drug: Riociguat (Adempas)

Interventions

Riociguat (Adempas) DRUG

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

Patients with Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Kam THH, Kam KKH, Wong MKL, Yan BPY, Tan G. Haemodynamic and clinical impacts of switching phosphodiesterase-5 inhibitors to riociguat in patients with chronic thromboembolic pulmonary hypertension (CTEPH) after balloon pulmonary angioplasty (BPA) - a prospective cohort study. BMC Pulm Med. 2026 Jan 3;26(1):42. doi: 10.1186/s12890-025-04069-y.

  PMID: 41484960 DERIVED

MeSH Terms

Interventions

riociguat

Central Study Contacts

Daniel Xu Nurse

CONTACT

+85235051518; danielxu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open-labelled, single-arm study

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): January 22, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

HK (1)