Finerenone and Kidney Outcomes in Patients With Heart Failure: The FINEARTS-HF Trial
- PMID: 39490700
- DOI: 10.1016/j.jacc.2024.10.091
Finerenone and Kidney Outcomes in Patients With Heart Failure: The FINEARTS-HF Trial
Abstract
Background: Finerenone has kidney-protective effects in patients with chronic kidney disease with type 2 diabetes, but effects on kidney outcomes in patients with heart failure with and without diabetes and/or chronic kidney disease are not known.
Objectives: The purpose of this study was to examine the effects of finerenone on kidney outcomes in FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure), a randomized trial of finerenone vs placebo among patients with heart failure with mildly reduced or preserved ejection fraction.
Methods: We explored the effects of finerenone on the secondary outcome of a sustained ≥50% estimated glomerular filtration rate (eGFR) decline or kidney failure (sustained eGFR decline <15 mL/min/1.73 m2; initiation of maintenance dialysis; renal transplantation). In this prespecified analysis, we also report effects of finerenone on: 1) sustained ≥57% eGFR decline or kidney failure; 2) eGFR slope; and 3) changes in urine albumin/creatinine ratio (UACR).
Results: Among 6,001 participants, mean baseline eGFR was 62 ± 20 mL/min/1.73 m2; 48% had eGFR <60 mL/min/1.73 m2. Overall, 5,797 had baseline UACR data (median: 18 mg/g [Q1-Q3: 7-67 mg/g]). Over 2.6 years median follow-up, the incidence of the composite kidney outcome (≥50% eGFR decline or kidney failure) was numerically, but nonsignificantly, higher for finerenone vs placebo (75 vs 55 events; HR: 1.33; 95% CI: 0.94-1.89). Similar results were observed for the composite of ≥57% eGFR decline or kidney failure (41 vs 31 events; HR: 1.28; 95% CI: 0.80-2.05), although the overall event frequency was relatively low. During the first 3 months, finerenone led to an acute decline in eGFR of -2.9 mL/min/1.73 m2 (95% CI: -3.4 to -2.4 mL/min/1.73 m2) but did not alter chronic (from 3 months) eGFR slope (+0.2 mL/min/1.73 m2 per year; 95% CI: -0.1 to 0.4 mL/min/1.73 m2 per year), vs placebo. The difference in total slope was -0.7 mL/min/1.73 m2 per year (95% CI: -0.9 to -0.4 mL/min/1.73 m2 per year.). Finerenone reduced UACR by 30% (95% CI: 25%-34%) over 6 months vs placebo, an effect that persisted throughout follow-up. Finerenone reduced the risk of new-onset of microalbuminuria and macroalbuminuria by 24% (HR: 0.76; 95% CI: 0.68-0.83) and 38% (HR: 0.62; 95% CI: 0.53-0.73), respectively.
Conclusions: In FINEARTS-HF, a population at low risk of adverse kidney outcomes, finerenone did not significantly modify the kidney composite outcomes. Finerenone led to a greater reduction in initial eGFR, but did not result in a significant difference in chronic eGFR slope vs placebo. Finerenone led to early and sustained reductions in albuminuria and reduced the risk of new-onset micro- and macroalbuminuria. (FINEARTS-HF [Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenon 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%]; NCT04435626).
Keywords: chronic kidney disease; finerenone; heart failure with mildly reduced ejection fraction; heart failure with preserved ejection fraction; safety.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures FINEARTS-HF was sponsored by Bayer. FINEARTS-HF was designed by the academic members of the executive committee in collaboration with representatives from Bayer. The sponsor, Bayer, was responsible for study supervision, site monitoring, and data collection. Primary data analysis was performed by Bayer and independent academic statisticians at the Brigham and Women’s Hospital, Boston, Massachusetts, USA. The present analyses were conducted by an independent academic group at Brigham and Women’s Hospital. All authors participated in the decision to submit the manuscript for publication with support from the study sponsor. Dr Mc Causland has received research funding from the National Institute of Diabetes and Digestive and Kidney Diseases, Satellite Healthcare, Fifth Eye, Novartis, and Lexicon paid directly to his institution; has received consulting fees from GlaxoSmithKline and Zydus Therapeutics; and has received expert witness fees from Rubin-Anders Scientific. Dr Vaduganathan has received research grant support, served on advisory boards, or had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Bristol Myers Squibb, Boehringer Ingelheim, Chiesi, Cytokinetics, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; and participates on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. Dr Claggett has received personal consulting fees from Alnylam, Bristol Myers Squibb, Cardior, Cardurion, Corvia, CVRx, Eli Lilly, Intellia, and Rocket; and has served on a data safety monitoring board for Novo Nordisk. Dr Desai has received institutional research grants (to Brigham and Women’s Hospital) from Abbott, Alnylam, AstraZeneca, Bayer, Novartis, and Pfizer; and has received personal consulting fees from Abbott, Alnylam, AstraZeneca, Bayer, Biofourmis, Boston Scientific, Medpace, Medtronic, Merck, Novartis, Parexel, Porter Health, Regeneron, River2Renal, Roche, Veristat, Verily, and Zydus. Dr Jhund has received speakers’ fees from AstraZeneca, Novartis, Alkem Laboratories, ProAdWise Communications, Sun Pharmaceuticals; has received advisory board fees from AstraZeneca, Boehringer Ingelheim, and Novartis; has received research funding from AstraZeneca, Boehringer Ingelheim, Analog Devices Inc, and Roche Diagnostics; his employer, the University of Glasgow, has been remunerated for clinical trial work from AstraZeneca, Bayer AG, Novartis, and Novo Nordisk; and he is Director of GCTP Ltd. Drs Brinker, Perkins, Scheerer, and Schloemer are full-time employees of Bayer. Dr Lam has received research support from Novo Nordisk and Roche Diagnostics; has received consulting fees from Alleviant Medical, Allysta Pharma, AnaCardio AB, Applied Therapeutics, AstraZeneca, Bayer, Biopeutics, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, CardioRenal, CPC Clinical Research, Eli Lilly, Impulse Dynamics, Intellia Therapeutics, Ionis Pharmaceutical, Janssen Research & Development LLC, Medscape/WebMD Global LLC, Merck, Novartis, Novo Nordisk, Prosciento Inc, Quidel Corporation, Radcliffe Group Ltd, Recardio Inc, ReCor Medical, Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics, and Us2.ai; and is a cofounder and non-executive director of Us2.ai. Dr Senni has served on advisory boards, been a consultant, or received honoraria from Novartis, Abbott, Merck, Merck Sharp and Dohme, Vifor, AstraZeneca, Cardurion, Novo Nordisk, Bayer, and Boehringer Ingelheim. Dr Shah has received research grants from the National Institutes of Health (U54 HL160273, X01 HL169712, R01 HL140731, R01 HL149423), American Heart Association (24SFRNPCN1291224), AstraZeneca, Corvia, and Pfizer; and has received consulting fees from Abbott, Alleviant, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Imara, Impulse Dynamics, Intellia, Ionis, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sardocor, Shifamed, Tenax, Tenaya, and Ultromics. Dr Voor’s employer has received consultancy fees and/or research support from Adrenomed, Anacardio, AstraZeneca, Bayer AG, Bristol Myers Squibb, Boehringer Ingelheim, Corteria, EliLilly, Merck, Moderna, Novartis, Novo Nordisk, Roche Diagnostics, and SalubrisBio. Dr Zannad has received personal fees from 89Bio, Abbott, Acceleron, Applied Therapeutics, Bayer, Betagenon, Boehringer, Bristol Myers Squibb, CVRx, Cambrian, Cardior, Cereno pharmaceutical, Cellprothera, CEVA, Inventiva, KBP, Merck, NovoNordisk, Owkin, Otsuka, Roche Diagnostics, Northsea, and USa2; has stock options at G3Pharmaceutical and equities at Cereno, Cardiorenal, Eshmoun Clinical research; and is the founder of Cardiovascular Clinical Trialists. Dr Pitt has served as a consultant for Bayer, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Lexicon, Anacardia, and G3 Pharmaceuticals; has served as a consultant and received stock options or stocks from Sea Star Medical, Vifor, scPharmaceuticals, SQinnovations, KBP Biosciences, Sarfez, Cereno Scientific, Prointel, and Brainstorm Medical; holds a U.S. Patent (9931412-site specific delivery of Eplerenone to the myocardium); and has a U.S. Patent pending (63/045,783 HistoneModulating agents for the prevention and treatment of organ damage). Dr McMurray has received payments through Glasgow University from work on clinical trials, consulting, and grants from Amgen, AstraZeneca, Bayer, Cardurion, Cytokinetics, GlaxoSmithKline, and Novartis; has received personal consultancy fees from Alynylam Pharmaceuticals, Amgen, AnaCardio, AstraZeneca, Bayer, Berlin Cures, Bristol Myers Squibb, Cardurion, Cytokinetics, Ionis Pharmaceuticals, Novartis, Regeneron Pharmaceuticals, River 2 Renal Corp, British Heart Foundation, National Institute for Health–National Heart, Lung, and Blood Institute, Boehringer Ingelheim, SQ Innovations, Catalyze Group; has received personal lecture fees from Abbott, Alkem Metabolics, AstraZeneca, Blue Ocean Scientific Solutions Ltd, Boehringer Ingelheim, Canadian Medical and Surgical Knowledge, Emcure Pharmaceuticals Ltd, Eris Lifesciences, European Academy of CME, Hikma Pharmaceuticals, Imagica Health, Intas Pharmaceuticals, J.B. Chemicals & Pharmaceuticals Ltd, Lupin Pharmaceuticals, Medscape/Heart.Org., ProAdWise Communications, Radcliffe Cardiology, Sun Pharmaceuticals, The Corpus, Translation Research Group, Translational Medicine Academy; has served on the Data Safety Monitoring Board fromWIRB-Copernicus Group Clinical Inc; and is a director of Global Clinical Trial Partners Ltd. Dr Solomon has received research grants from Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, Bristol Myers Squibb, Boston Scientific, Cytokinetics, Edgewise, Eidos/Bridgebio, Gossamer, GlaxoSmithKline, Ionis, Intellia, Lilly, NIH/NHLBI, Novartis, Novo Nordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, and US2.AI; and has consulted for Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Bristol Myers Squibb, Cardior, Cardurion, Corvia, Cytokinetics, GlaxoSmithKline, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, and Valo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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