Abstract Body (Do not enter title and authors here): Background: Finerenone has been shown to improve overall health status, as measured by the aggregate summary scores of the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ), in patients with heart failure and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). A comprehensive understanding of the improvement in individual KCCQ components would allow clinicians and patients to understand the expected changes in daily living with treatment.
Methods: This is a prespecified analysis of the FINEARTS-HF trial, a double-blind randomized comparison of finerenone with placebo in patients with symptomatic HF and left ventricular ejection fraction (LVEF) ≥40%. KCCQ was administered at randomization and at 6, 9, and 12 months. Each of the 23 individual KCCQ components was scaled from 0 (worst symptoms) to 100 (best symptoms). Mean score changes from randomization to 12 months for each 23 KCCQ components were examined using multivariable linear regression models, adjusting for each corresponding baseline KCCQ value.
Results: Of the 6,001 randomized participants in the FINEARTS-HF trial, KCCQ data were available for 5,987 at randomization, of whom 5,006 (83% of the overall population) completed KCCQ assessment at 12 months (mean age: 72±10 years, women: 45%, NYHA class II: 71%, and mean LVEF: 53±8%). Among the 23 items of KCCQ, the greatest nominal significant improvements with finerenone were observed in the frequency of lower limb edema (difference: 2.5, 95%CI: 0.9-4.1), burden of fatigue (difference: 2.2, 95%CI: 0.9-3.5), frequency of fatigue (difference: 2.1, 95%CI: 0.7-3.6), and burden of lower limb edema (difference: 1.8, 95%CI: 0.6-2.9) (all P<0.01) (Figure). Longitudinal analyses integrating data from months 6, 9, and 12 were consistent with the main results. The proportion of patients with worsening score from randomization to 12 months was numerically lower with finerenone versus placebo for most individual KCCQ components.
Conclusions: In the FINEARTS-HF trial of patients with HFmrEF/HFpEF, finerenone was associated with improvement in a broad range of individual KCCQ components, with the greatest benefits seen in domains related to symptom frequency, symptom burden, and social limitations.