Efficacy of Verciguat in TR and RV Failure
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaejeon St. Mary's hospital
About this trial
The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function. It will also examine the effects of the drug on tricuspid regurgitation (TR) and overall clinical outcomes.
The main questions it aims to answer are:
Does vericiguat improve right ventricular (RV) function and reduce tricuspid regurgitation (TR)? Does vericiguat reduce the risk of major adverse cardiovascular events (MACE), such as heart failure hospitalizations and cardiovascular death? Does vericiguat improve participants' exercise capacity, quality of life, and renal function?
Researchers have previously seen the benefits of vericiguat in the large-scale VICTORIA trial for worsening heart failure, and it is hypothesized that improvements in right heart function play a key role. This study aims to confirm these specific benefits.
Participants will:
Take vericiguat as prescribed during the study period. Undergo echocardiograms at enrollment and at 9 months to assess right heart function.
Complete questionnaires (KCCQ-12) and walking tests (6MWT) to evaluate quality of life and exercise capacity.
Provide blood samples to monitor NTproBNP levels and renal function (creatinine).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age more than 19 years old
right ventricular malfunction confirmed with EKG data or cardiac MRI
chronic heart failure with LVEF<45%
Patients Who administrated standard treatment of Heart Failur for over the 4 weeks
Disqualifiers
Patients with a systolic blood pressure (SBP) < 100 mmHg
Patients currently treated with other sGC stimulators (including vericiguat) or phosphodiesterase-5 (PDE5) inhibitors
Moderate-to-severe right ventricular (RV) failure requiring surgical intervention
Patients who are currently pregnant or of childbearing potential
Trial design
Design model
Parallel
Treatments tested in this trial
Vericiguat
DrugParticipants will start vericiguat at 2.5 mg once daily, and the dose will be gradually uptitration every 2 weeks to a target dose of 10 mg once daily, depending on tolerability.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Arm with administered with VericiguatExperimental treatment 1 intervention
Group B: Arm with standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
NTproBNP
Time frame
NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.2
Echocardiographic RV function parameters
RVSP, RV volume, TAPSE, RV strain/PAP, TR grade
Time frame
From enrollment to the end of treatment at baseline and 9 monthsSecondary outcomes
1
Composite endpoint of Major Adverse Cardiovascular Events (MACE)
Composite endpoint of Major Adverse Cardiovascular Events (MACE), including hospitalization for heart failure (requiring a minimum of 24 hours of hospitalization and intravenous diuretic therapy) and cardiovascular death.
Time frame
From enrollment to the end of treatment at 9 months2
Exercise capacity and quality of life
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame
From enrollment to the end of treatment at baseline and 9 months3
6-Minute Walk Test (6MWT distance)
6-Minute Walk Test (6MWT distance)
Time frame
From enrollment to the end of treatment at baseline and 9 months4
Renal Function
Renal function: Serum creatinine (Cr)
Time frame
from enrollment to the end of treatment at baseline, 3 and 9 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daejeon St. Mary's hospital
Lead sponsor
Seoul St. Mary's Hospital
Collaborator
Uijeongbu St. Mary Hospital
Collaborator
Incheon St.Mary's Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: