Finerenone
Management of Patients with Heart Failure whose Left Ventricular Ejection Fraction
Declines to <40% During Treatment
SUMMARY
- The randomized, double-blind, multicenter, event-driven Phase III FINEARTS-HF study evaluated the efficacy and safety of finerenone (at a target dose of 20 mg or 40 mg once daily depending on baseline estimated glomerular filtration rate [eGFR]) vs placebo, in 6001 patients with symptomatic heart failure (HF) (New York Heart Association [NYHA] class II-IV) and left ventricular ejection fraction (LVEF) ≥40% with or without diabetes and/or chronic kidney disease.1-4
- Patients with a previous LVEF <40% with subsequent improvement to ≥40% by the time of enrollment were eligible if ongoing HF symptoms were present and all other inclusion criteria were met.3 However, no data were identified regarding change in LVEF to values below 40% during the study. Change in LVEF was not listed as an exploratory variable according to the study protocol.1,2
- An ongoing Phase III, international, randomized, double-blind, placebo-controlled study (FINALITY-HF) is assessing the efficacy and safety of finerenone in patients with HF with reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (MRAs). 5
- According to international guidelines, steroidal MRAs (spironolactone or eplerenone) have a class 1 recommendation in patients with LVEF ≤40% (HFrEF).6,7 In patients with HF with improved ejection fraction (defined in the guideline as those with a previous HFrEF who now have an LVEF >40%) after treatment, guideline-directed medical therapy should be continued to prevent relapse of HF and LV dysfunction, even in patients who may become asymptomatic.7
This page is intended for US healthcare professionals and may contain information outside of the approved prescribing information. It is provided in response to an unsolicited request. It is not intended as an endorsement of any usage not contained in the Prescribing Information. This response should be reviewed together with the current full Prescribing Information (including Boxed Warning) and Medical Safety Summary. These materials contain the approved indications, contraindications, warnings and precautions, adverse reactions, and other important safety information for Kerendia® (Finerenone).
Kerendia is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) indicated to: reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with Type 2 diabetes mellitus (T2DM); reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with Type 1 diabetes mellitus (T1DM); reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (LVEF) ≥ 40%.
CLINICAL DATA
Phase III study
In the randomized, double-blind, multicenter, event-driven Phase III FINEARTS-HF study, mean (standard deviation [SD]) age was 72 (10) years. Approximately 46% of patients were female. The mean (±SD) LVEF was 53±8% (range, 34-84%); 36% of patients had an LVEF of 40-49% and 64% had an LVEF ≥50%. The mean duration of follow-up was 32 months.1-4
The FINEARTS-HF enrolled patients with a documented LVEF ≥40% measured by any modality within the last 12 months.2 Patients with a previous LVEF <40% with subsequent improvement to ≥40% by the time of enrollment were eligible if ongoing HF symptoms were present and all other inclusion criteria were met.3 There are no data available regarding change in LVEF to percentages below 40% from the study. Change in LVEF was not an exploratory variable according to the study protocol.2
Treatment with the study intervention or placebo continued unless discontinuation criteria were met; patients with an LVEF below 40% were not specifically listed among these criteria. Study intervention was prematurely and permanently discontinued if any of the following occurred2 :
- Pregnancy of the participant.
- The investigator determined that continuation of study intervention was harmful to the participant’s well-being.
- The randomization code was broken by the investigator, or another responsible person, when knowledge of the participant’s treatment was required.
- Any investigational drug other than the study intervention is used.
- Any suspected drug-related adverse event (AE) or serious AE.
- If any exclusion criterion applied during treatment.
- Participant requires treatment with an MRA (such as eplerenone, spironolactone, exerenonone).
- If a significant protocol violation occured, as defined by the sponsor and the coordinating investigator.
Ongoing trial
FINALITY-HF is a Phase III, international, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of finerenone in patients with HFrEF who are intolerant or ineligible to receive treatment with steroidal MRAs. The primary outcomes are time to first cardiovascular death or HF event, number of serious AEs, and number of AEs leading to discontinuation of finerenone. The study plans to enroll 2600 patients with a study duration of up to 30 months. More study details can be found at: NCT06033950.5
LITERATURE SEARCH
A literature search of Embase®, PubMed®, and/or other resources, including internal/external databases, was conducted pertaining to this topic on 29 August 2026.
REFERENCES
- Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024;391(16):1475-1485. PMID: 39225278 https://pubmed.ncbi.nlm.nih.gov/39225278/
- Protocol for: Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024;391(16):1475-1485. Accessed via https://www.nejm.org/doi/suppl/10.1056/NEJMoa2407107/suppl_file/nejmoa2407107_proto col.pdf
- Solomon SD, Ostrominski JW, Vaduganathan M, et al. Baseline characteristics of patients with heart failure with mildly reduced or preserved ejection fraction: The FINEARTS-HF trial. Eur J Heart Fail. 2024;26(6):1334-1346. PMID: 38733212 https://pubmed.ncbi.nlm.nih.gov/38733212/
- Docherty KF, Henderson AD, Jhund PS, et al. Efficacy and Safety of Finerenone Across the Ejection Fraction Spectrum in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the FINEARTS-HF Trial. Circulation. 2025;151(1):45- 58. PMID: 39342512 https://pubmed.ncbi.nlm.nih.gov/39342512/
- ClinicalTrials.gov. A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists. Identifier: NCT06033950. Updated March 11, 2025. Accessed 25 August 2026. Available at: https://clinicaltrials.gov/study/NCT06033950
- McDonagh TA, Metra M, Adamo M, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-3726. PMID: 34447992 https://www.ncbi.nlm.nih.gov/pubmed/34447992
- Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18):e876-e894. PMID: 35363500 https://pubmed.ncbi.nlm.nih.gov/35363500/
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