Finerenone and Kidney Outcomes in Patients With Heart Failure The FINEARTS-HF Trial

被引:3
作者
Mc Causland, Finnian R. [1 ]
Vaduganathan, Muthiah [1 ]
Claggett, Brian L. [1 ]
Kulac, Ian J. [1 ]
Desai, Akshay S. [1 ]
Jhund, Pardeep S. [2 ]
Henderson, Alasdair D. [2 ]
Brinker, Meike [3 ]
Perkins, Robert [4 ]
Scheerer, Markus F. [5 ]
Schloemer, Patrick [6 ]
Lam, Carolyn S. P. [7 ,8 ]
Senni, Michele [9 ]
Shah, Sanjiv J. [10 ]
Voors, Adriaan A. [11 ]
Zannad, Faiez [12 ]
Pitt, Bertram [13 ]
Mcmurray, John J. V. [2 ]
Solomon, Scott D. [1 ]
机构
[1] Harvard Med Sch, Brigham & Womens Hosp, Boston, MA USA
[2] Univ Glasgow, Glasgow, Scotland
[3] Bayer AG, Res & Dev, Pharmaceut, Wuppertal, Germany
[4] Bayer US, US Med Affairs, Whippany, NJ USA
[5] Bayer AG, Global Med Affairs, Berlin, Germany
[6] Bayer AG, Res & Dev, Pharmaceut, Berlin, Germany
[7] Singapore & Duke Natl Univ Singapore, Singapore, Singapore
[8] Duke Natl Univ Singapore, Singapore, Singapore
[9] Milano Bicocca Univ, ASST Papa Giovanni XXIII Hosp, Largo Barozzi 1, I-24128 Bergamo, Italy
[10] Northwestern Univ, Feinberg Sch Med, Chicago, IL USA
[11] Univ Groningen, Groningen, Netherlands
[12] Univ Lorraine, Nancy, France
[13] Univ Michigan, Ann Arbor, MI USA
关键词
chronic kidney disease; nerenone; heart failure with mildly reduced ejection fraction; heart failure with preserved ejection fraction; safety; ALBUMINURIA; DISEASE;
D O I
10.1016/j.jacc.2024.10.091
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 m(2); 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 m(2); 48% had eGFR <60 mL/min/1.73 m(2). 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 m(2) (95% CI:-3.4 to-2.4 mL/min/1.73 m(2)) but did not alter chronic (from 3 months) eGFR slope (+0.2 mL/min/1.73 m(2) per year; 95% CI:-0.1 to 0.4 mL/min/1.73 m(2) per year), vs placebo. The difference in total slope was-0.7 mL/min/1.73 m(2) per year (95% CI:-0.9 to-0.4 mL/min/1.73 m(2) 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) (JACC. 2025) (c) 2025 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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页码:159 / 168
页数:10
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