WASHINGTON, May 26, 2025 (APMnews) – Patients with heart failure whose left ventricular ejection fraction (LVEF) has improved remain at high risk for cardiovascular events and benefit from treatment with finerenone (Kerendia*, Bayer) to reduce this risk, according to a predefined analysis of the FINEARTS-HF trial published in JAMA Cardiology.
"Advances in the management of heart failure with reduced ejection fraction have led to an increasing number of patients transitioning to heart failure with improved ejection fraction," observed Maria Pabon of the Division of Cardiology at Brigham and Women’s Hospital, Harvard Medical School in Boston, and colleagues in a brief report.
However, “gaps in knowledge remain due to the lack of a standardized definition and the exclusion of heart failure with improved ejection fraction from major heart failure clinical trials.”
Patients with chronic heart failure and improved LVEF may still carry residual cardiovascular risks that require continued management.
The FINEARTS-HF trial included 6,001 patients with heart failure and an LVEF ≥40%, enrolled between September 14, 2020, and January 10, 2023. Participants were randomized 1:1 to receive either finerenone or placebo in addition to standard therapy. Among these patients, 273 (5%) had heart failure with improved ejection fraction, having a history of LVEF <40% with a median improvement of 12%. Of these, 147 received finerenone and 126 received placebo.
The primary endpoint was a composite of cardiovascular death and worsening heart failure (including both first and recurrent events), defined as unplanned hospitalisations or urgent visits due to heart failure.
Over a median follow-up of 2.6 years, the incidence of the primary outcome in the placebo group was 21.4 events per 100 patient-years for those with prior LVEF <40%, compared to 16 events per 100 patient-years for those whose LVEF had always been preserved (≥40%). Thus, the former group had a 33% higher risk, although the difference was no longer statistically significant after adjustment—still indicating a higher-risk population.
For secondary endpoints, including heart failure events and all-cause mortality, the risks were similar between the two groups.
Among participants with a history of LVEF <40%, finerenone reduced the relative risk of the primary outcome by 28%, compared to a 15% reduction in those with consistently preserved LVEF. While the difference between groups was not statistically significant, the absolute risk reduction was greater among patients with heart failure and improved ejection fraction (9.2 vs. 2.5 events per 100 patient-years), due to their higher baseline risk.
Finerenone was well tolerated in both groups, with no significant differences in serious adverse events. However, patients with improved ejection fraction were more likely to have a systolic blood pressure below 100 mmHg compared to those with preserved ejection fraction.
“In this predefined analysis, patients with a history of LVEF <40% experienced similar rates of adverse cardiovascular events as the rest of the trial population, highlighting that LVEF improvement does not guarantee cardiac recovery or eliminate residual heart failure risk,” the authors noted.
These findings “support the use of finerenone in combination with other medical therapies (such as SGLT2 inhibitors) in the management of heart failure with improved ejection fraction.”
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