Patients with heart failure are at their highest risk in the period following a worsening heart failure event1. In heart failure with mildly reduced or preserved ejection fraction, data on steroidal mineralocorticoid receptor antagonists have not shown conclusive benefit2. In the FINEARTS-HF trial, finerenone reduced a primary composite of cardiovascular death and total worsening heart failure events in this population1. However, only about one third of FINEARTS-HF participants had been recently hospitalized1. REDEFINE-HF will extend the science beyond FINEARTS-HF by focusing on this high-risk population.
“The importance of this trial continues to be highlighted by the fact that recent data from SPIRIT-HF again did not show benefit with spironolactone in patients with heart failure with preserved ejection fraction. Now with both TOPCAT and SPIRIT-HF not reaching their primary endpoint, the potential differences between steroidal versus non-steroidal MRA are further highlighted.”
Dr. J. Butler
Early initiation and up titration of standard guideline directed medical therapy is linked to better outcomes3. The combination of SGLT2i and finerenone has been shown to be beneficial in patients with kidney disease4. CONFIRMATION-HF aims to expand on the existing science from STRONG-HF to demonstrate the safety and efficacy of early combined initiation of novel therapies in patients with heart failure.
“What excites me the most about the evolution of treatment options for heart failure is the fact that we now see efficacy and safety from the rapid addition and dose optimization of numerous therapies. CONFIRMATION-HF is important for the field because it adds finerenone use to the conceptual framework of STRONG-HF.”
Dr. J. Januzzi
Steroidal mineralocorticoid receptor antagonists reduce death and heart failure events in patients with heart failure and reduced ejection fraction5. Despite this evidence, across registries 30–70% of these patients remain untreated, and a substantial proportion of non-use reflects intolerance or ineligibility rather than clinical inertia alone6. FINALITY-HF aims to address this gap by evaluating finerenone in patients with heart failure and reduced ejection fraction who remain untreated with a steroidal MRA.
“A significant gap remains. Far too many patients are still being denied one of the most effective disease-modifying therapies due to intolerance or safety concerns. FINALITY-HF is our opportunity to change that, to demonstrate that an effective alternative exists, and to ensure no patient is left behind.”
Dr. J. McMurray
- Desai AS, Vaduganathan M, et al. Finerenone in Patients With a Recent Worsening Heart Failure Event: The FINEARTS-HF Trial. J Am Coll Cardiol. 2025 Jan 21;85(2):106-116. ↩︎
- Pitt B, Pfeffer MA, et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. ↩︎
- Mebazaa A, Davison B,et al. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. ↩︎
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. ↩︎
- Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17. ↩︎
- Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. ↩︎