Effect of Dapagliflozin on Accelerometer-Based Measures of Physical Activity in Patients With Heart Failure: An Analysis of the DETERMINE Trials.

IF 7.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Circulation: Heart Failure Pub Date : 2024-10-01 Epub Date: 2024-08-30 DOI:10.1161/CIRCHEARTFAILURE.124.012349

Kieran F Docherty, Ruben Buendia Lopez, Folke Folkvaljon, Rudolf A de Boer, Martin R Cowie, Ann Hammarstedt, Dalane W Kitzman, Mikhail N Kosiborod, Anna Maria Langkilde, Barry Reicher, Michele Senni, Sanjiv J Shah, Subodh Verma, Scott D Solomon, John J V McMurray

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Abstract

Background: Wearable accelerometers can quantify the frequency and intensity of physical activity during everyday life and may provide complementary data to established functional outcome measures on the effect of heart failure therapies on functional limitations.

Methods: In a voluntary substudy of the DETERMINE trials (Dapagliflozin Effect on Exercise Capacity Using a 6-Minute Walk Test in Patients With Heart Failure), patients wore a waist-worn triaxial accelerometer for as long as possible (ideally for 24 h/d for 7 days) at 3 points during the trial, between the screening visit and randomization (baseline data), and during weeks 8 and 14 to 16. Accelerometer outcomes included the change from baseline to week 16 in the total number of steps, time spent in light-to-vigorous physical activity, time spent in moderate-to-vigorous physical activity, movement intensity during walking, number of vector magnitude units' and total activity counts.

Results: Adequate baseline and week 16 accelerometer data were available for 211 of 817 (26%) randomized patients (defined as ≥10 hours of wear time for ≥3 days). Dapagliflozin had a favorable effect on the mean change from baseline at 16 weeks in the number of steps (between-group difference, 778 [95% CI, 240-1315]), time spent in moderate-to-vigorous physical activity (0.16 [95% CI, 0.03-0.29] hours), and in the mean vector magnitude units (25 [95% CI, 0.1-49] counts per minute). There were no between-group differences in the other accelerometer outcomes of interest.

Conclusions: In this exploratory analysis of the DETERMINE trials, dapagliflozin had a beneficial effect on selected accelerometer-based measures of physical activity in patients with heart failure across the entire left ventricular ejection fraction spectrum, yet did not improve 6-minute walk distance, as previously reported. These data suggest that accelerometer-based measurements of everyday activity may provide complementary information to 6-minute walk distance and identify beneficial effects of treatment not detected by 6-minute walk distance.

Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT03877237 and NCT03877224.

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达帕格列净对基于加速计的心衰患者体力活动测量的影响：DETERMINE试验分析。

背景：可穿戴加速度计可量化日常生活中的体力活动频率和强度，可为心衰疗法对功能限制的影响提供既有功能结果测量的补充数据。研究方法在DETERMINE（达帕格列净对心力衰竭患者运动能力的影响，采用6-MINutE步行测试）试验的一项自愿子研究中，患者在试验期间的3个时间点尽可能长时间（最好每天24小时，连续7天）佩戴腰部三轴加速度计；筛查访问和随机化之间（基线数据），以及第8周和第14-16周。加速度计的结果包括从基线到第 16 周的总步数变化、轻度至高强度体力活动（LVPA）时间、中度至高强度体力活动（MVPA）时间、步行时的运动强度、矢量幅度单位（VMU）数量和总活动次数。研究结果817 名随机患者中有 211 人（26%）获得了充足的基线和第 16 周加速度计数据（定义为佩戴时间≥10 小时且≥3 天）。达帕格列净对 16 周时步数（组间差异为 778 [95%CI 240, 1315]）、MVPA 时间（0.16 小时 [95%CI 0.03, 0.29]）和平均 VMU（每分钟 25 次 [95%CI 0.1, 49]）与基线相比的平均变化产生了有利影响。加速度计的其他相关结果没有组间差异。结论：在这项对 DETERMINE 试验的探索性分析中，达帕格列净在整个左心室射血分数范围内对选定的基于加速度计的高血压患者体力活动测量具有有益的影响，但并没有像之前报道的那样改善 6MWD 。这些数据表明，基于加速度计的日常活动测量可为 6MWD 提供补充信息，并确定 6MWD 未检测到的治疗效果。试验注册：URL: https://clinicaltrials.gov 唯一标识符：NCT03877237 和 NCT03877224。

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来源期刊

Circulation: Heart Failure 医学-心血管系统

CiteScore

12.90

自引率

3.10%

发文量

271

审稿时长

6-12 weeks

期刊介绍： Circulation: Heart Failure focuses on content related to heart failure, mechanical circulatory support, and heart transplant science and medicine. It considers studies conducted in humans or analyses of human data, as well as preclinical studies with direct clinical correlation or relevance. While primarily a clinical journal, it may publish novel basic and preclinical studies that significantly advance the field of heart failure.