Table 1.
VICTORIA [9] (Patients: 5050) |
VICTOR [48] (Patients: 6000) |
|
---|---|---|
Vericiguat 2526 female 1921 male Placebo 2524 female 1921 male |
Ongoing | |
Study drug | Vericiguat vs. placebo | Vericiguat vs. placebo |
Key inclusion criteria | Chronic HF with NYHA functional class II–IV EF < 45% Receiving HF GDMT Prior HF hospitalization within 6 months or outpatient intravenous diuretic for HF within 3 months Elevated NT-proBNP levels |
Chronic HF with NYHA functional class II–IV EF ≤ 40% Elevated NT-proBNP levels |
Primary endpoint | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization The first event of CV death or HF hospitalization as confirmed by a clinical event committee (CEC) |
Select secondary endpoints | Time to CV death Time to first HFH Time to total (first and recurrent) HFHs Time to total first occurrence of composite of all-cause mortality or HFH Time to all-cause mortality Safety and tolerability |
Time to first occurrence of CV First event of CV death as confirmed by CEC Time to first occurrence of HF hospitalization The first event of HF hospitalization as confirmed by CEC Time to total HF hospitalizations, all events of HF hospitalization as confirmed by CEC Safety and tolerability |
Randomized Double-blind 1:1 |
2.5 mg od/5 mg od/10 mg od (up-titration at 2-week intervals) Placebo |
2.5, 5.0, or 10.0 mg orally once daily Placebo |
Median follow-up | 10.8 months | 40.0 months |