Abstract
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.