Finerenone and Kidney Outcomes in Patients With Heart Failure: The FINEARTS-HF Trial

Background: Finerenone has kidney-protective effects in patients with chronic kidney disease with type 2 diabetes, but effects on kidney outcomes in patients with heart failure with and without diabetes and/or chronic kidney disease are not known. Objectives: The purpose of this study was to examine the effects of finerenone on kidney outcomes in FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure), a randomized trial of finerenone vs placebo among patients with heart failure with mildly reduced or preserved ejection fraction. Methods: We explored the effects of finerenone on the secondary outcome of a sustained ≥50% estimated glomerular filtration rate (eGFR) decline or kidney failure (sustained eGFR decline <15 mL/min/1.73 m2; initiation of maintenance dialysis; renal transplantation). In this prespecified analysis, we also report effects of finerenone on: 1) sustained ≥57% eGFR decline or kidney failure; 2) eGFR slope; and 3) changes in urine albumin/creatinine ratio (UACR). Results: Among 6,001 participants, mean baseline eGFR was 62 ± 20 mL/min/1.73 m2; 48% had eGFR <60 mL/min/1.73 m2. Overall, 5,797 had baseline UACR data (median: 18 mg/g [Q1-Q3: 7-67 mg/g]). Over 2.6 years median follow-up, the incidence of the composite kidney outcome (≥50% eGFR decline or kidney failure) was numerically, but nonsignificantly, higher for finerenone vs placebo (75 vs 55 events; HR: 1.33; 95% CI: 0.94-1.89). Similar results were observed for the composite of ≥57% eGFR decline or kidney failure (41 vs 31 events; HR: 1.28; 95% CI: 0.80-2.05), although the overall event frequency was relatively low. During the first 3 months, finerenone led to an acute decline in eGFR of −2.9 mL/min/1.73 m2 (95% CI: −3.4 to −2.4 mL/min/1.73 m2) but did not alter chronic (from 3 months) eGFR slope (+0.2 mL/min/1.73 m2 per year; 95% CI: −0.1 to 0.4 mL/min/1.73 m2 per year), vs placebo. The difference in total slope was −0.7 mL/min/1.73 m2 per year (95% CI: −0.9 to −0.4 mL/min/1.73 m2 per year.). Finerenone reduced UACR by 30% (95% CI: 25%-34%) over 6 months vs placebo, an effect that persisted throughout follow-up. Finerenone reduced the risk of new-onset of microalbuminuria and macroalbuminuria by 24% (HR: 0.76; 95% CI: 0.68-0.83) and 38% (HR: 0.62; 95% CI: 0.53-0.73), respectively. Conclusions: In FINEARTS-HF, a population at low risk of adverse kidney outcomes, finerenone did not significantly modify the kidney composite outcomes. Finerenone led to a greater reduction in initial eGFR, but did not result in a significant difference in chronic eGFR slope vs placebo. Finerenone led to early and sustained reductions in albuminuria and reduced the risk of new-onset micro- and macroalbuminuria. (FINEARTS-HF [Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenon on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants with Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%]; NCT04435626)