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American Heart Association

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Final ID: MP2233

Effects of Finerenone on Heart Failure Outcomes According to Baseline Heart Failure Risk: Insights from the FIDELITY Program

Abstract Body (Do not enter title and authors here):
Introduction: The non-steroidal mineralocorticoid receptor antagonist finerenone reduces the risk of heart failure (HF) hospitalization in people with type 2 diabetes and chronic kidney disease (CKD), but whether these benefits vary according to baseline HF risk is uncertain.

Purpose: To evaluate the relative and absolute effects of finerenone on HF outcomes across different levels of HF risk, based on the Thrombolysis in Myocardial Infarction Risk Score for Heart Failure in Diabetes (TRS-HFDM).

Methods: We conducted a post-hoc individual participant data analysis of the FIDELITY program, consisting of the FIDELIO-DKD and FIGARO-DKD trials, which assessed the efficacy and safety of finerenone versus placebo on clinical outcomes in people with type 2 diabetes and albuminuric CKD. TRS-HFDM is a validated integer-based score (0-7 points) to predict HF events based on 5 clinical variables (history of HF [2 points], history of atrial fibrillation, history of coronary artery disease, eGFR <60 mL/min/1.73m2, UACR 30-300 mg/g, UACR >300 mg/g [2 points]). Participants were categorized into 4 groups according to TRS-HFDM score at baseline (0-1, 2, 3, 4+). Relative and absolute treatment effects on HF hospitalization or cardiovascular death were examined across TRS-HFDM score categories.

Results: Of 12,990 participants, 12,984 (99.95%) had available data to calculate TRS-HFDM. The proportion of participants who had a score of 0-1, 2, 3, and 4+, were 7.3%, 34.9%, 37.9%, and 19.9%, respectively. Compared with placebo, finerenone reduced the risk of time-to-first HF hospitalization or cardiovascular death (HR, 0.83; 95% CI, 0.74-0.93) with consistent relative effect across TRS-HFDM risk categories (Pinteraction=0.89; Figure 1). Relative effects on HF hospitalization (HR, 0.78; 95% CI, 0.66-0.92) and cardiovascular death (HR, 0.88; 95% CI, 0.76-1.02) were similarly consistent across TRS-HFDM risk categories (Pinteraction=0.42 and 0.90, respectively; Figure 1). Absolute risk reductions for HF hospitalization or cardiovascular death appeared greater across higher TRS-HFDM risk categories with fewer corresponding numbers needed to treat to prevent one outcome (Figure 2).

Conclusions: In people with type 2 diabetes and CKD, finerenone reduces the risk of HF hospitalization or cardiovascular death, with greater absolute benefits in people at higher risk for HF events.
  • Ostrominski, John  ( Brigham and Womens Hospital , Boston , Massachusetts , United States )
  • Brinker, Meike  ( Bayer AG , Sao Paulo SP , Brazil )
  • Schloemer, Patrick  ( Bayer AG , Berlin , Germany )
  • Rohwedder, Katja  ( Bayer AG , Berlin , Germany )
  • Mcmurray, John  ( BHF CARDIOVASCULAR RESEARCH CENTRE , Glasgow , United Kingdom )
  • Solomon, Scott  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Vaduganathan, Muthiah  ( Brigham and Womens Hospital , Boston , Massachusetts , United States )
  • Neuen, Brendon  ( George Institute for Global Health , Newtown , New South Wales , Australia )
  • Claggett, Brian  ( Brigham and Women's Hospital , Boston , Massachusetts , United States )
  • Agarwal, Rajiv  ( VA Indianapolis , INDIANAPOLIS , Indiana , United States )
  • Anker, Stefan  ( charite , Berlin , Germany )
  • Filippatos, Gerasimos  ( NKUA , Chaidari , Greece )
  • Rossing, Peter  ( Steno Diabetes Center Copenhagen , Gentofte , Denmark )
  • Ruilope, Luis  ( Hospital 12 de Octubre , Madrid , Spain )
  • Amarante, Flaviana  ( Bayer AG , Sao Paulo SP , Brazil )
  • Author Disclosures:
    John Ostrominski: DO NOT have relevant financial relationships | Meike Brinker: No Answer | Patrick Schloemer: DO have relevant financial relationships ; Employee:Bayer AG:Active (exists now) | Katja Rohwedder: DO have relevant financial relationships ; Employee:Bayer AG:Active (exists now) | John McMurray: DO NOT have relevant financial relationships | Scott Solomon: DO have relevant financial relationships ; Research Funding (PI or named investigator):Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cytokinetics, Edgewise, Eidos/BridgeBio, Gossamer, GSK, Ionis, Lilly,NIH/NHLBI, Novartis, NovoNordisk, Respicardia, Sanofi Pasteur, Tenaya, Theracos, US2.AI:Active (exists now) ; Consultant:Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, Askbio, AstraZeneca, Bayer, BMS, Cardior, Cardurion, Corvia, Cytokinetics, GSK, Intellia, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi-Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, Valo, Synhale, Recordati:Active (exists now) | Muthiah Vaduganathan: DO have relevant financial relationships ; Consultant:American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Bristol Myers Squibb, Boehringer Ingelheim, Chiesi, Cytokinetics, Esperion, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi and Tricog Health:Active (exists now) ; Research Funding (PI or named investigator):Amgen, AstraZeneca, Boehringer Ingelheim, Galmed, Novartis, Bayer AG, Occlutech, Pharmacosmos, and Impulse Dynamics:Active (exists now) | Brendon Neuen: DO have relevant financial relationships ; Consultant:AstraZeneca:Active (exists now) ; Other (please indicate in the box next to the company name):Menarini - publication support:Active (exists now) ; Consultant:Travere:Active (exists now) ; Consultant:Otsuka:Active (exists now) ; Consultant:Novo Nordisk:Active (exists now) ; Other (please indicate in the box next to the company name):CSL Behring - travel support:Active (exists now) ; Consultant:CSL Seqirus:Active (exists now) ; Consultant:Boehringer and Ingelheim:Active (exists now) ; Consultant:Bayer:Active (exists now) ; Consultant:Alexion:Active (exists now) | Brian Claggett: No Answer | Rajiv Agarwal: No Answer | Stefan Anker: DO have relevant financial relationships ; Research Funding (PI or named investigator):CSL/Vifor & Abbott Laboratories.:Past (completed) ; Royalties/Patent Beneficiary:Named co-inventor of two patent applications regarding MR-proANP (DE 102007010834 & DE 102007022367), but he does not benefit personally from the related issued patents.:Active (exists now) ; Consultant:Actimed, Alleviant, Astra Zeneca, Bayer, Berlin Heals, Boehringer Ingelheim, Brahms, Cardiac Dimensions, Cardior, Cordio, CVRx, Cytokinetics, Edwards, Impulse Dynamics, Lilly, Mankind Pharma, Novo Nordisk, Occlutech, Pfizer, Regeneron, Relaxera, Repairon, Scirent, Sensible Medical, Vectorious, Vivus, & V-Wave:Active (exists now) | Gerasimos Filippatos: DO have relevant financial relationships ; Research Funding (PI or named investigator):European Union:Active (exists now) ; Advisor:MSD:Active (exists now) ; Other (please indicate in the box next to the company name):Vifor/Trial Committee member:Past (completed) ; Advisor:Servier:Past (completed) ; Other (please indicate in the box next to the company name):Medtronic/ Trial Committee member:Past (completed) ; Advisor:Boehringer Ingelheim:Active (exists now) ; Advisor:Bayer:Active (exists now) ; Advisor:Novo Nordisc:Active (exists now) ; Other (please indicate in the box next to the company name):Windtree?Trial Committee:Active (exists now) ; Other (please indicate in the box next to the company name):Impulse/Trial Committee:Active (exists now) ; Advisor:Novartis:Past (completed) | Peter Rossing: DO have relevant financial relationships ; Consultant:Novo Nordisk A/S:Active (exists now) ; Consultant:Abbott:Past (completed) ; Consultant:Sanofi:Past (completed) ; Consultant:Gilead:Past (completed) ; Consultant:Eli Lilly:Active (exists now) ; Speaker:daichii sankyo:Past (completed) ; Consultant:Boehringer Ingelheim:Active (exists now) ; Other (please indicate in the box next to the company name):Lexicon:Active (exists now) ; Consultant:Roche:Active (exists now) ; Consultant:amgen:Active (exists now) ; Consultant:AstraZeneca:Active (exists now) ; Consultant:Bayer:Active (exists now) | Luis Ruilope: No Answer | Flaviana Amarante: DO have relevant financial relationships ; Employee:Bayer AG:Active (exists now)
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Heart Failure in CKM Syndrome: Prevention, Management and Outcomes

Monday, 11/10/2025 , 01:45PM - 02:55PM

Moderated Digital Poster Session

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