Switching of Sildenafil to Riociguat in CTEPH Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Riociguat (Adempas)
DrugOral 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
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with Chronic Thromboembolic Pulmonary HypertensionOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
26 weeks2
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.
Time frame
26 weeksSecondary outcomes
1
Change in cardiac output (CO)
Change in cardiac output (CO) measured in right heart catheterization. Cardiac output (CO) is the product of the heart rate (HR), i.e. the number of heartbeats per minute (bpm), and the stroke volume (SV), which is the volume of blood pumped from the left ventricle per beat.
Time frame
26 weeks2
Change in cardiac index (CI)
Change in cardiac index (CI) measured in right heart catheterization. The cardiac index (CI) is a hemodynamic measure that represents the cardiac output (CO) of an individual divided by their body surface area (BSA). It is crucial in assessing patients with heart failure and other cardiovascular conditions
Time frame
26 weeks3
Change in pulmonary artery wedge pressure (PAWP)
Change in pulmonary artery wedge pressure (PAWP) measured in right heart catheterization. It is the pressure measured by wedging a pulmonary artery catheter with an inflated balloon into a small pulmonary arterial branch
Time frame
26 weeks4
Change in The World Health Organization (WHO) functional class
Change in WHO functional class describes how severe a patient's pulmonary hypertension (PH) symptoms. There are four different classes - I is the mildest and IV the most severe form of PH.
Time frame
26 weeksSponsors and contacts
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Source ClinicalTrials.gov