Finerenone Benefits in HF With Mildly Reduced or Preserved Ejection Fraction Regardless of Baseline Risk: JAMA
UK: A secondary analysis of the FINEARTS-HF randomized clinical trial evaluated the performance of the PREDICT-HFpEF model in estimating heart failure risk and its potential role in guiding finerenone therapy.
The study, published in JAMA Cardiology, demonstrated that patients with heart failure with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF) benefit from finerenone, regardless of baseline risk. The PREDICT-HFpEF models also performed well in calibration and discrimination, confirming their reliability.
For this purpose, the researchers conducted the FINEARTS-HF trial across 653 sites in 37 countries, enrolling adults aged 40 years and older with symptomatic heart failure and a left ventricular ejection fraction of 40% or greater. Participants were randomized between September 2020 and January 2023 to receive finerenone (titrated to 20 mg or 40 mg) or a placebo.
The study assessed the three PREDICT-HFpEF risk scores for cardiovascular death or heart failure hospitalization, cardiovascular death alone, and all-cause mortality. Predicted risk was compared with observed outcomes, and model performance was evaluated using the Harrell C statistic. The rates of predicted outcomes, including the composite of cardiovascular death and worsening heart failure events, were analyzed across risk quintiles, along with the effect of finerenone in different risk categories.
The study led to the following findings:
- The FINEARTS-HF trial included 6001 patients with a mean age of 72 years, with 54.5% being male.
- The PREDICT-HFpEF model performed well in predicting cardiovascular outcomes, with C statistics of 0.71 for cardiovascular death or heart failure hospitalization, 0.68 for cardiovascular death, and 0.69 for all-cause death at two years.
- Patients in the highest risk quintile had an 8- to 10-fold greater risk of composite outcomes than those in the lowest quintile.
- Finerenone consistently reduced risk across all patient groups, with no significant difference in effect based on baseline risk.
The researchers demonstrated that the PREDICT-HFpEF model effectively assessed risk in patients with HFmrEF or HFpEF, showing strong calibration and discrimination. Despite the wide range of risk levels among participants, the baseline risk did not alter the therapeutic benefits of finerenone. Those at the highest risk experienced the most significant absolute benefit when the drug was added to their treatment.
"These findings highlight the consistent efficacy of finerenone across risk groups and support the integration of predictive models like PREDICT-HFpEF to enhance individualized heart failure management," the researchers concluded.
They noted limitations, including trial-specific patient selection, and limiting generalizability. One missing variable may have affected accuracy, and socioeconomic factors were not analyzed. Additionally, alternative HFpEF risk scores may provide different predictive insights.
Reference:
McDowell K, Docherty KF, Campbell RT, et al. Finerenone for Heart Failure and Risk Estimated by the PREDICT-HFpEF Model: A Secondary Analysis of FINEARTS-HF. JAMA Cardiol. Published online March 05, 2025. doi:10.1001/jamacardio.2025.0025
