Table 3.

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

Trial	Inclusion criteria	Methods	Endpoints	Results
SOCRATES-PRESERVED Phase: IIB Year of publication: 2017	HF with LVEF >45% (NYHA II–IV) BNP ≥100 ng/L (≥200 ng/L if AF) or NT-proBNP ≥300 ng/L (>600 ng/L if AF) at randomization LA enlargement assessed on TT echocardiogram Recent episode of HF decompensation (within <4 weeks) defined as worsening of symptoms requiring hospitalization or IV use of diuretic	Total patients: 477 Randomization: Placebo: 93 1.25 mg: 96 2.5 mg: 95 5 mg: 95 10 mg: 96 Follow-up: 12 weeks	Reduction in NT-proBNP levels and LA volume (mL) at 12 weeks	No significant difference in NT-proBNP and LA volume (mL) [p = 0.15] between the vericiguat ‘pooled’ and placebo groups Secondary analyses focused on the 10 mg group evidenced: the KCCQ Clinical Summary Score improved by a mean 19.3 ± 16.3 points (median 19.8, IQR 10.4–30.7) from baseline (mean difference from placebo 9.2 points)
VITALITY HFpEF Phase: IIB Year of publication: 2020	HF with LVEF >45% (NYHA II–IV) BNP ≥100 ng/L (≥200 ng/L if AF) or NT-proBNP ≥300 ng/L (>600 ng/L if AF) within 30 days after randomization Left atrium enlargement or left ventricular hypertrophy assessed by TT echocardiogram within 12 months after randomization Recent episode of HF decompensation (within 6 months) defined as worsening of symptoms requiring hospitalization or IV use of diuretic	Total patients: 789 Randomization: Placebo: 262 10 mg: 263 15 mg: 264 Follow-up: 24 weeks	Change in the KCCQ PLS Change in 6-min walking distance	No significant difference between the three groups

AF atrial fibrillation, BNP brain natriuretic peptide, HF heart failure, HFpEF heart failure with preserved ejection fraction, IQR interquartile range, IV intravenous, KCCQ Kansas City Cardiomyopathy Questionnaire, LA left atrium, LVEF left ventricular ejection fraction, NT-proBNP N-terminal pro-brain natriuretic peptide, NYHA New York Heart Association, PLS Physical Limitation Score, TT transthoracic