Aims To describe the baseline characteristics of participants in the FINEARTS-HF trial,
contextualized with prior trials including patients with heart failure (HF) with mildly
reduced and preserved ejection fraction (HFmrEF/HFpEF). The FINEARTS-HF trial is comparing
the effects of the non-steroidal mineralocorticoid receptor antagonist finerenone
with placebo in reducing cardiovascular death and total worsening HF events in patients
with HFmrEF/HFpEF. Methods and results Patients with symptomatic HF, left ventricular
ejection fraction (LVEF) >= 40%, estimated glomerular filtration rate >= 25 ml/min/1.73
m(2), elevated natriuretic peptide levels and evidence of structural heart disease
were enrolled and randomized to finerenone titrated to a maximum of 40 mg once daily
or matching placebo. We validly randomized 6001 patients to finerenone or placebo
(mean age 72 +/- 10 years, 46% women). The majority were New York Heart Association
functional class II (69%). The baseline mean LVEF was 53 +/- 8% (range 34-84%); 36%
of participants had a LVEF <50% and 64% had a LVEF >= 50%. The median N-terminal pro-B-type
natriuretic peptide (NT-proBNP) was 1041 (interquartile range 449-1946) pg/ml. A total
of 1219 (20%) patients were enrolled during or within 7 days of a worsening HF event,
and 3247 (54%) patients were enrolled within 3 months of a worsening HF event. Compared
with prior large-scale HFmrEF/HFpEF trials, FINEARTS-HF participants were more likely
to have recent (within 6 months) HF hospitalization and greater symptoms and functional
limitations. Further, concomitant medications included a larger percentage of sodium-glucose
cotransporter 2 inhibitors and angiotensin receptor-neprilysin inhibitors than previous
trials. Conclusions FINEARTS-HF has enrolled a broad range of high-risk patients with
HFmrEF and HFpEF. The trial will determine the safety and efficacy of finerenone in
this population. [GRAPHICS]
