The following are key points to remember from the FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure):

1. The FINEARTS-HF was the first international, multicenter, parallel-group, event-driven, double-blind randomized trial to assess the efficacy of finerenone in patients with ejection fraction (EF) >40%.¹
2. The trial demonstrated a reduction in the risk of the composite primary outcome of total worsening heart failure (HF) events and death from cardiovascular (CV) causes by 16% (rate ratio, 0.84; 95% confidence interval [CI], 0.74-0.95; p = 0.007). The benefit was driven by a reduction in worsening HF events, with no evidence of a reduction in CV mortality.
3. The primary outcome was achieved mainly by reduction in hospitalization for worsening HF (rate ratio, 0.82; 95% CI, 0.71-0.94; p = 0.006). Death from CV causes was not statistically significant (hazard ratio, 0.93; 95% CI, 0.78-1.11). This trend has been seen in all the recent trials in HF with mildly reduced and preserved EF.²
4. There were no differences or interactions between the different subgroups, even in patients with sodium-glucose cotransporter-2 treatment and range of EF. The trial also included up to 5% of patients with HF with recovered EF.
5. The main adverse event in the finerenone group was systolic blood pressure <100 mm Hg (18.5% vs. 12.4%); the mean systolic pressure variation was 3.2 mm Hg.
6. Hyperkalemia was more frequent in the finerenone group (9.7% vs. 4.2%), with very few serious events due to potassium alterations. This incidence of hyperkalemia is almost half the incidence in the data from the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial of spironolactone.³
7. There was an improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score but no change in New York Heart Association (NYHA) functional class.
8. Compared with previous trials, this trial used the highest dose of finerenone, reaching up to 40 mg daily.^3,4
9. The kidney composite outcome was not met in the active treatment arm, although that outcome was met in a previous trial with finerenone.⁵ The population in the FINEARTS-HF had a low risk of kidney progression with low prevalence of albuminuria.
10. Finerenone is the first medication acting on the renin-angiotensin-aldosterone system to prove beneficial effect on this population.

References

1. Solomon SD, McMurray JJV, Vaduganathan M, et al.; FINEARTS-HF Committees and Investigators. Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med 2024;391:1475-85.
2. Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med 2022;387:1089-98.
3. Filippatos G, Anker SD, Agarwal R, et al.; FIDELIO-DKD Investigators. Finerenone and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes. Circulation 2021;143:540-52.
4. Pitt B, Pfeffer MA, Assmann SF, et al.; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med 2014;370:1383-92.
5. Agarwal R, Filippatos G, Pitt B, et al.; FIDELIO-DKD and FIGARO-DKD investigators. Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis. Eur Heart J 2022;43:474-84.