Finerenone in Patients With a Recent Worsening Heart Failure Event
Akshay S. DesaiMuthiah VaduganathanBrian ClaggettIan J. KulacPardeep S. JhundJonathan W. CunninghamMaria BorentainJames Lay‐FlurriePrabhakar ViswanathanKatja RohwedderFlaviana AmaranteMichele SenniSanjiv J. ShahAdriaan A. VoorsFaı̈ez ZannadBertram PittMikhail KosiborodJohn J.V. McMurrayScott D. Solomon
Key result
Finerenone suggests enhanced benefit for worsening HF and CV death after a recent HF event.
- P=0.011
Why the study?
Patients with heart failure and recent worsening heart failure are at high risk of recurrent hospitalization and death, but the efficacy and safety of finerenone according to recency of worsening heart failure was unstudied.
Does finerenone reduce the composite of total WHF events and CV death in patients with HF and LVEF ≥40%?
Key Points
- This study examines the efficacy and safety of finerenone in heart failure patients with a recent worsening heart failure event.
- Randomized, double-blind, placebo-controlled trial
- Involves patients with heart failure and left ventricular ejection fraction ≥40%
- Assessed cardiovascular events risk based on time since recent worsening heart failure event
- Finerenone showed a significant reduction in the composite of total worsening heart failure events and cardiovascular death (p=0.011)
- No increased risk of adverse events like hyperkalemia in patients with recent worsening heart failure
- Patients with recent worsening heart failure events had a higher risk for recurrent events compared to those without.
Study Design
Type
RCT
Blinding
double-blind
Randomization
randomized
Structured PICO
Does finerenone reduce the composite of total WHF events and CV death in patients with HF and LVEF ≥40%?
P
Population
Patients with heart failure and left ventricular ejection fraction ≥40% analyzed by recency of worsening heart failure event.
I
Intervention
Finerenone
C
Comparator
Placebo
O
Outcome
Composite of total (first and recurrent) WHF events and CV deathcomposite
Main Result
p-value: p=0.011
Finerenone shows a possible signal of enhanced absolute treatment benefit in HF patients with LVEF ≥40% and a recent worsening heart failure event, without increased risk of hyperkalemia or worsening renal function.
Limitations
- Requires further confirmation in future studies
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“I think it is important in interpreting these data to highlight that while provocative and hypothesis-generating, they do not conclusively suggest that the benefit of finerenone is confined to those with a recent—within 3 months—worsening HF event. As with all subgroup analyses, the primary trial result should rule unless there is compelling evidence of a treatment effect by subgroup interaction, and there was no such interaction identified here.”
“Until additional data emerges, I believe that in the absence of any mortality benefit overall, and the apparent absence or minimal benefit in this subgroup of patients, there is not a compelling need to initiate finerenone in patients who have no recent worsening heart failure event.”
JBJaved ButlerCardiologist, Baylor Scott & White Research Institute
“These are really important results because not only will it influence the care of the patients today, I can bet you that this will influence future clinical trial designs as well.”
Implication
Finerenone may yield larger absolute reductions soon after WHF; leaves open whether recency modifies relative efficacy in HFmrEF/HFpEF.
Abstract
BACKGROUND: Patients with heart failure (HF) and a recent worsening heart failure (WHF) event are known to be at high risk of recurrent hospitalization and death, regardless of ejection fraction. OBJECTIVES: This study examined the efficacy and safety of the nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone in relation to the recency of a WHF event. METHODS: FINEARTS-HF (FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure) was a randomized, double-blind, placebo-controlled trial of finerenone in patients with HF and left ventricular ejection fraction ≥40%. In this prespecified analysis, we assessed the risk of cardiovascular (CV) events and response to finerenone vs placebo in relation to the time from WHF to randomization (during or within 7 days, 7 days to 3 months, >3 months, or no prior WHF). The primary outcome was a composite of total (first and recurrent) WHF events and CV death, analyzed using a proportional rates method. The risk of adverse events including hyperkalemia and worsening renal function among patients assigned to finerenone was not increased in those with recent WHF. CONCLUSIONS: Compared with those without recent WHF, patients with HF and mildly reduced or preserved ejection fraction who have experienced a recent WHF event are at higher risk for recurrent HF events and CV death; a possible signal of enhanced absolute treatment benefit with finerenone in this population requires further confirmation in future studies. (Study to Evaluate the Efficacy [Effect on Disease] and Safety of Finerenone 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% [FINEARTS-HF], NCT04435626; A study to gather information on the influence of study drug finerenone on the number of deaths and hospitalizations in participants with heart failure EudraCT 2020-000306-29).
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Cite This Study
Desai et al. (2024) conducted an RCT in Heart failure with left ventricular ejection fraction ≥40%. Finerenone vs. Placebo was evaluated on Composite of total (first and recurrent) worsening heart failure events and cardiovascular death (p=0.011). Finerenone showed a possible signal of enhanced absolute treatment benefit for total worsening heart failure events and cardiovascular death in patients with a recent worsening heart failure event (P=0.011).