Heart failure due to systemic left ventricular systolic dysfunction
Conditions
Brief summary
Base Period: Change from baseline to Week 16 in log-transformed n-terminal pro-brain natriuretic peptide (NT-proBNP), Extension Period: Percentage of participants with one or more adverse events (AE), Extension Period: Percentage of participants who discontinued study drug due to an AE
Detailed description
Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP, Base Period: Time from randomization to the first event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization, Base Period: Percentage of participants with one or more adverse events (AE), Base Period: Percentage of participants who discontinued study drug due to an AE, Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat, Base Period: Half-life (t1/2) of vericiguat in plasma, Base Period: Oral clearance (CL/F) of plasma vericiguat, Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Base Period: Change from baseline to Week 16 in log-transformed n-terminal pro-brain natriuretic peptide (NT-proBNP), Extension Period: Percentage of participants with one or more adverse events (AE), Extension Period: Percentage of participants who discontinued study drug due to an AE | — |
Secondary
| Measure | Time frame |
|---|---|
| Base Period: Change from baseline to Week 52 in log-transformed NT-proBNP, Base Period: Time from randomization to the first event of cardiovascular (CV) death, heart failure hospitalization (HFH), or worsening of heart failure (HF) without hospitalization, Base Period: Percentage of participants with one or more adverse events (AE), Base Period: Percentage of participants who discontinued study drug due to an AE, Base Period: Area under the curve from time 0-24 hours post-dose (AUC0-24) of plasma vericiguat, Base Period: Half-life (t1/2) of vericiguat in plasma, Base Period: Oral clearance (CL/F) of plasma vericiguat, Extension Period: Change from extension period baseline to extension period Week 16 in NT-proBNP | — |
Countries
Belgium, Croatia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Sweden