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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Participants 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.
Daejeon St.Mary's Hospital
Daejeon, South Korea
NTproBNP
Time frame: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.
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 months
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 months
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 months
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 months
Renal Function
Renal function: Serum creatinine (Cr)
Time frame: from enrollment to the end of treatment at baseline, 3 and 9 months.
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