Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction.
In the FINEARTS-HF trial, the nonsteroidal mineralocorticoid receptor antagonist finerenone significantly reduced the composite of total worsening heart failure events and cardiovascular death in patients with heart failure and mildly reduced or preserved ejection fraction.
Background
Steroidal mineralocorticoid receptor antagonists reduce morbidity and mortality in heart failure with reduced ejection fraction, but their efficacy in patients with mildly reduced or preserved ejection fraction had not been established. Data were needed on the nonsteroidal agent finerenone in this population, which accounts for a large share of heart failure cases yet has limited proven therapies.
Study design
This international, double-blind trial randomly assigned patients with heart failure and a left ventricular ejection fraction of 40% or greater in a 1:1 ratio to finerenone (maximum dose 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 (first or recurrent unplanned hospitalization or urgent visit) and death from cardiovascular causes, assessed over a median follow-up of 32 months.
Key findings
Primary-outcome events occurred in 624 of 3003 patients in the finerenone group versus 719 of 2998 in the placebo group (rate ratio 0.84; 95% CI 0.74 to 0.95; P=0.007). Total worsening heart failure events were 842 with finerenone versus 1024 with placebo (rate ratio 0.82; 95% CI 0.71 to 0.94; P=0.006). Cardiovascular death occurred in 8.1% versus 8.7% (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.
Clinical implications
In patients with heart failure and mildly reduced or preserved ejection fraction, finerenone significantly lowered the rate of the composite of total worsening heart failure events and cardiovascular death compared with placebo. The benefit was driven primarily by a reduction in worsening heart failure events, supporting finerenone as a therapeutic option in this population while warranting monitoring for hyperkalemia.
Category
Research
Source
N Engl J Med
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