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. 2024 Jun 10;24(4):469–479. doi: 10.1007/s40256-024-00652-6

Table 2.

Clinical trials evaluating vericiguat in HF patients with <45% LVEF

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