Lee Sahmin, Claggett Brian L, Fang James C, Mitchell Gary F, Ward Jonathan H, Solomon Scott D, Skali Hicham, Desai Akshay S, Hegde Sheila M
Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.
Division of Cardiology, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Eur J Heart Fail. 2025 Jul 18. doi: 10.1002/ejhf.3760.
This analysis aims to investigate the relationship between changes in cardiac structure and function and changes in health-related quality of life in patients with heart failure with reduced ejection fraction (HFrEF).
The association between echocardiographic measures and Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 scores was examined in HFrEF patients of the EVALUATE-HF trial who were randomized to sacubitril-valsartan or enalapril for 12 weeks followed by 12 weeks of open-label sacubitril-valsartan for both groups. We used linear regression models adjusted for age, sex, treatment assignment at randomization, baseline KCCQ-12 score, baseline echo measurements, and other clinical variables. Among 406 patients (median age 67 years; 25% women), the KCCQ-12 overall summary score (KCCQ-12-OSS) improved by +9 points (95% confidence interval +7 to +11 points) over 24 weeks. Increases in mitral e' velocities correlated with KCCQ-12-OSS improvement (+2.5 and +2.3 points per standard deviation [SD] increase in septal and lateral e' velocities, respectively, p < 0.05 for each). Decreases in septal E/e' ratio and left atrial volume index (LAVi) also correlated with KCCQ-12-OSS improvement (+3.2 and +2.0 points per SD decrease in septal E/e' ratio and LAVi, respectively, p < 0.05 for each). Changes in left ventricular size, ejection fraction, longitudinal strain, and right ventricular function were not associated with changes in KCCQ-12-OSS. Similar associations were observed for other KCCQ-12 domains.
In the EVALUATE-HF trial, increases in mitral e' velocities and decreases in septal E/e' ratio and LAVi were associated with improved KCCQ-12 scores over 24 weeks, after adjusting for treatment assignment. These findings suggest that reductions in left ventricular filling pressures and left atrial size are closely coupled with improved physical function and quality of life in HFrEF patients, which may provide insights into the early benefits of sacubitril-valsartan.
ClinicalTrials.gov Identifier: NCT02874794.
本分析旨在研究射血分数降低的心力衰竭（HFrEF）患者心脏结构和功能变化与健康相关生活质量变化之间的关系。
在EVALUATE-HF试验的HFrEF患者中，研究了超声心动图测量指标与堪萨斯城心肌病问卷（KCCQ）-12评分之间的关联。这些患者被随机分为沙库巴曲缬沙坦组或依那普利组，治疗12周，随后两组均接受12周的开放标签沙库巴曲缬沙坦治疗。我们使用线性回归模型，并对年龄、性别、随机分组时的治疗分配、基线KCCQ-12评分、基线超声测量值及其他临床变量进行了校正。在406例患者（中位年龄67岁；25%为女性）中，KCCQ-12总体总结评分（KCCQ-12-OSS）在24周内提高了9分（95%置信区间为7至11分）。二尖瓣e'速度的增加与KCCQ-12-OSS的改善相关（间隔和侧壁e'速度每增加1个标准差[SD]分别增加2.5分和2.3分，每项p<0.05）。间隔E/e'比值和左心房容积指数（LAVi）的降低也与KCCQ-12-OSS的改善相关（间隔E/e'比值和LAVi每降低1个SD分别增加3.2分和2.0分，每项p<0.05）。左心室大小、射血分数、纵向应变和右心室功能的变化与KCCQ-12-OSS的变化无关。在KCCQ-12的其他领域也观察到了类似的关联。
在EVALUATE-HF试验中，校正治疗分配后，二尖瓣e'速度的增加以及间隔E/e'比值和LAVi的降低与24周内KCCQ-12评分的改善相关。这些发现表明，左心室充盈压和左心房大小的降低与HFrEF患者身体功能和生活质量的改善密切相关，这可能为沙库巴曲缬沙坦的早期获益提供见解。
ClinicalTrials.gov标识符：NCT02874794。
