This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.
Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.
Has biventricular physiology with a morphologic systemic left ventricle.
Is currently receiving stable medical therapy for HF.
Has left ventricular ejection fraction (LVEF) <45% assessed within 3 months before randomization.
Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic.
Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.
Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.
Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.
Parallel
Vericiguat tablet
Drug2.5 mg or 5 mg or 10 mg vericiguat administered orally once daily in tablet form
Vericiguat suspension
Drug0.2 mg/mL or 1 mg/mL vericiguat administered orally once daily in suspension form
Placebo tablet
DrugPlacebo for vericiguat administered orally once daily in tablet form
Placebo suspension
DrugPlacebo for vericiguat administered orally once daily in suspension form
Base Period: Change from baseline to Week 16 in N-terminal pro-brain natriuretic peptide (NT-proBNP)
The change from baseline to Week 16 of the Base Period in log-transformed NT-proBNP will be reported.
Extension Period: Percentage of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Extension Period will be reported.
Extension Period: Percentage of participants who discontinued study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Extension Period due to an AE will be reported.
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP
The change from baseline to Week 52 of the Base Period in log-transformed NT-proBNP will be reported.
Base Period: First event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization
The time from randomization to the first event of CV death, HFH, or worsening of HF without hospitalization will be reported for the Base Period.
Base Period: Percentage of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with one or more AEs in the Base Period will be reported.
Base Period: Percentage of participants who discontinued study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug in the Base Period due to an AE will be reported.
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