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Effect of Finerenone on the KCCQ in Patients With HFmrEF/HFpEF
Mingming YangAlasdair D HendersonAtefeh TalebiJ. AthertonChern‐En ChiangVijay ChopraJosep Comín‐ColetMikhail KosiborodJose F. Kerr SaraivaBrian ClaggettAkshay S. DesaiPeter KolkhofPrabhakar ViswanathanAndrea LageCarolyn S.P. LamMichele SenniSanjiv J. ShahKatja RohwedderAdriaan A. VoorsFaı̈ez ZannadBertram PittMuthiah VaduganathanPardeep S. JhundScott D. SolomonJohn J.V. McMurray
Key result
Finerenone improves 12-month KCCQ symptom scores by ~1.6 points vs. placebo in HFmrEF/HFpEF.
- MD 1.62 points
- 95% CI 0.69-2.56
- P<0.001
Why the study?
Patients with HF have impaired quality of life, and the efficacy and safety of finerenone according to baseline KCCQ-TSS as well as its effect on KCCQ-TSS were evaluated.
Does finerenone improve health status (KCCQ-TSS) and reduce cardiovascular events in patients with HFmrEF/HFpEF?
Study Design
Type
RCT
Randomization
Randomized
Structured PICO
Does finerenone improve health status (KCCQ-TSS) and reduce cardiovascular events in patients with HFmrEF/HFpEF?
P
Population
Patients with heart failure and left ventricular ejection fraction ≥40% (HFmrEF/HFpEF) stratified by baseline KCCQ Total Symptom Score tertiles and assessed through 12 months.
I
Intervention
Finerenone
C
Comparator
Placebo
O
Outcome
Composite of cardiovascular death and total worsening HF eventspatient reported
Main Result
Mean Difference: 1.62 (95% CI 0.69–2.56)
p-value: p=<0.001
Finerenone significantly improves patient-reported health status and reduces heart failure events in patients with HFmrEF/HFpEF, regardless of baseline symptom severity.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Finerenone significantly reduced HF events and improved health status in HFmrEF/HFpEF across the spectrum of KCCQ-TSS at baseline,”
“In the FINEARTS (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure) trial, finerenone produced an 18% reduction in the risk of hospitalizations for heart failure but yielded uninterpretable and clinically questionable changes in KCCQ, with the small possibility of a modest benefit in <2% of randomized patients.”
Implication
Finerenone improves health status in HFmrEF/HFpEF; extends evidence for its benefits on symptoms alongside event reduction.
Abstract
BACKGROUND: Patients with heart failure (HF) are limited by symptoms and have impaired quality of life. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient-reported outcome measure that enables evaluation of the effect of HF and the impact of new therapies on health status in patients with HF. OBJECTIVES: This prespecified analysis of FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure) assessed the efficacy and safety of finerenone according to baseline KCCQ Total Symptom Score (TSS) and the effect of finerenone on KCCQ-TSS. METHODS: FINEARTS-HF tested the efficacy of the nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone, compared with placebo, in patients with HF with mildly reduced ejection fraction/preserved ejection fraction. The primary endpoint was the composite of cardiovascular death and total worsening HF events. The KCCQ was completed by patients at randomization and at 6, 9, and 12 months after randomization. Change in KCCQ-TSS was a key secondary endpoint. Patients were stratified by KCCQ-TSS tertiles at baseline. The association between KCCQ tertile and clinical outcomes was evaluated using semiparametric proportional-rates models for total events and Cox models for time-to-first-event data, and the effects of finerenone vs placebo on the primary endpoint were assessed across tertiles of KCCQ-TSS. Compared with placebo, finerenone significantly improved KCCQ-TSS from baseline with a mean difference at 12 months of 1.62 points (95% CI: 0.69-2.56 points) (P < 0.001). Numerically fewer finerenone-treated patients experienced clinically meaningful deterioration, and more had improvements in KCCQ-TSS. CONCLUSIONS: Finerenone significantly reduced HF events and improved health status in patients with HF and mildly reduced ejection fraction/preserved ejection fraction across the spectrum of KCCQ-TSS at baseline. (Study to Evaluate the Efficacy [Effect on Disease] and Safety of Finerenone 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% [FINEARTS-HF], NCT04435626; Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure; EudraCT 2020-000306-29).
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Cite This Study
Yang et al. (2024) conducted an RCT in Heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). Finerenone vs. Placebo was evaluated on Composite of cardiovascular death and total worsening heart failure events (key secondary endpoint reported in results: 12-month change in KCCQ Total Symptom Score) (MD 1.62 points, 95% CI 0.69-2.56, p=<0.001). Finerenone significantly improved 12-month KCCQ-TSS compared with placebo in patients with HFmrEF/HFpEF (mean difference 1.62 points; 95% CI 0.69-2.56; P<0.001).