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. 2022 Oct 3;10(10):2471. doi: 10.3390/biomedicines10102471

Table 4.

Summary of the main results data from the SOCRATES-PRESERVED and VITALITY trials.

Trial Inclusion Criteria Patients Treatment Results
SOCRATES-PRESERVED [30]
  • HFpEF (LVEF ≥ 45%),

  • <4 weeks from HF decompensation

  • NYHA II-IV,

  • BNP ≥ 100 ng/L or NT-proBNP ≥ 300 ng/L (BNP ≥ 200 ng/L or NT-proBNP ≥ 600 ng/L if AF),

  • Left atrial enlargement.

477 (325 patients completed treatment) Vericiguat fixed-dose treatment arms (1.25 mg or 2.5 mg) and vericiguat up-titrated treatment arms (2.5–5 mg, 2.5–10 mg daily) vs. placebo
  • Primary endpoint: no significant difference change in NT-proBNP levels (p = 0.20) and change in LAV (p = 0.37) from baseline vs. placebo to 12 weeks.

  • Exploratory endpoint: improve KCCQ score change from baseline (mean difference: 19.8 points) vs. placebo (mean difference: 9.2 points) to 12 weeks.

VITALITY [31]
  • HFpEF (LVEF ≥ 45%),

  • NYHA II-III,

  • HFH or HF requiring iv diuretics < 6 months,

  • BNP ≥ 100 ng/L or NT-proBNP ≥ 300 ng/L (BNP ≥ 200 ng/L or NT-proBNP ≥ 600 ng/L if AF),

  • Left ventricular hypertrophy or left atrial enlargement.

789 (761 included in primary analysis) Vericiguat (up-titrated to 15 mg or 10 mg) vs. placebo
  • Primary endpoint: no significant change in KCCQ to 24 weeks.

  • Secondary outcome: no difference in 6MWT to 24 weeks.

6MWT = six-minute walk test; AF = atrial fibrillation; BNP = B-type natriuretic peptide; HFH = heart failure hospitalization; HFpEF = heart failure with preserved ejection fraction; KCCQ = Kansas City Cardiomyopathy Questionnaire; LAV = left atrial volume; NT-proBNP = N-terminal pro-B-type natriuretic peptide; NYHA = New York Heart Association.