Background Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality
among patients with heart failure and reduced ejection fraction, but their efficacy
in those with heart failure and mildly reduced or preserved ejection fraction has
not been established. Data regarding the efficacy and safety of the nonsteroidal mineralocorticoid
receptor antagonist finerenone in patients with heart failure and mildly reduced or
preserved ejection fraction are needed.Methods In this international, double-blind
trial, we randomly assigned patients with heart failure and a left ventricular ejection
fraction of 40% or greater, in a 1:1 ratio, to receive finerenone (at a maximum dose
of 20 mg or 40 mg once daily) or matching placebo, in addition to usual therapy. The
primary outcome was a composite of total worsening heart failure events (with an event
defined as a first or recurrent unplanned hospitalization or urgent visit for heart
failure) and death from cardiovascular causes. The components of the primary outcome
and safety were also assessed.Results Over a median follow-up of 32 months, 1083 primary-outcome
events occurred in 624 of 3003 patients in the finerenone group, and 1283 primary-outcome
events occurred in 719 of 2998 patients in the placebo group (rate ratio, 0.84; 95%
confidence interval [CI], 0.74 to 0.95; P=0.007). The total number of worsening heart
failure events was 842 in the finerenone group and 1024 in the placebo group (rate
ratio, 0.82; 95% CI, 0.71 to 0.94; P=0.006). The percentage of patients who died from
cardiovascular causes was 8.1% and 8.7%, respectively (hazard ratio, 0.93; 95% CI,
0.78 to 1.11). Finerenone was associated with an increased risk of hyperkalemia and
a reduced risk of hypokalemia.Conclusions In patients with heart failure and mildly
reduced or preserved ejection fraction, finerenone resulted in a significantly lower
rate of a composite of total worsening heart failure events and death from cardiovascular
causes than placebo. (Funded by Bayer; FINEARTS-HF ClinicalTrials.gov number, NCT04435626.)
In patients with heart failure and mildly reduced or preserved ejection fraction,
finerenone resulted in a lower rate of total worsening heart failure events and death
from cardiovascular causes than placebo.
