Table 2.
Trial | Inclusion criteria | Methods | Endpoints | Results |
---|---|---|---|---|
SOCRATES-REDUCED Phase: IIB Year of publication: 2015 |
HF with LVEF <45% Recent episode of HF decompensation defined by three components: (1) hospitalization or outpatient administration of IV diuretics; (2) signs of congestion; (3) natriuretic peptide level |
Total patients: 351 Randomization: Placebo: 92 1.25 mg: 92 2.5 mg: 91 5 mg: 91 10 mg: 91 Follow-up: 12 weeks |
Reduction in levels of NT-proBNP at 12 weeks |
No significant difference (p = 0.15) between the vericiguat ‘pooled’ and placebo groups Secondary analyses focused on the 10 mg group evidenced a reduction in NTproBNP levels (p = 0.48); increase in LVEF (p = 0.02); and decrease of CV deaths + HF hospitalizations |
VICTORIA Phase: III Year of publication: 2020 |
HF with LVEF <45% (NYHA II–IV) BNP ≥300 ng/L (≥500 ng/L if AF), or NT-proBNP ≥1000 ng/L (≥1600 ng/L if AF) History of hospitalization (within 6 months) or IV diuretic use (within 3 months) |
Total patients: 5050 Randomization: Placebo: 2524 10 mg: 2526 Follow-up: 10.8 months |
Mortality from CV causes + HF hospitalization Mortality from CV causes HF hospitalization |
37.9% in the vericiguat group versus 40.9% in the placebo group (HR 0.90, 95% CI 0.83–0.98; p = 0.02) 16.4% in the vericiguat group versus 17.5% in the placebo group (HR 0.93, 95% CI 0.81–1.06) 27.4% in the vericiguat group versus 29.6% in the placebo group (HR 0.90, 95% CI 0.81–1.00) |
AF atrial fibrillation, BNP brain natriuretic peptide, CI confidence interval, CV cardiovascular, HF heart failure, HR hazard ratio, IV intravenous, LVEF left ventricular ejection fraction, NT-proBNP N-terminal pro-brain natriuretic peptide, NYHA New York Heart Association