达格列净对心力衰竭患者基于加速度计的身体活动测量的影响：DETERMINE 试验分析。
Effect of Dapagliflozin on Accelerometer-Based Measures of Physical Activity in Patients With Heart Failure: An Analysis of the DETERMINE Trials.
机构信息
British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Scotland, United Kingdom (K.F.D., J.J.V.M.).
Data Science, Late-Stage Development, Cardiovascular, Renal and Metabolic (R.B.L.), BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden.
出版信息
Circ Heart Fail. 2024 Oct;17(10):e012349. doi: 10.1161/CIRCHEARTFAILURE.124.012349. Epub 2024 Aug 30.
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.
背景
可穿戴加速度计可量化日常生活中身体活动的频率和强度，并且可能为既定的功能结局测量提供补充数据，以评估心力衰竭治疗对功能限制的影响。
方法
在心力衰竭患者使用 6 分钟步行试验评估达格列净对运动能力的影响（DETERMINE 试验的自愿亚研究）中，患者在试验期间的 3 个时间点（筛选访视和随机分组时[基线数据]，以及第 8 周和第 14 至 16 周）尽可能长时间（理想情况下每天 24 小时佩戴 7 天）佩戴腰部三轴加速度计。加速度计的结果包括从基线到第 16 周的总步数、轻至剧烈体力活动时间、中至剧烈体力活动时间、步行时的运动强度、向量幅度单位数量和总活动计数的变化。
结果
在随机分组的 817 例患者中，有 211 例（26%）患者具有足够的基线和第 16 周的加速度计数据（定义为≥10 小时的佩戴时间且至少 3 天）。达格列净在第 16 周时，总步数（组间差异为 778[95%CI，240-1315]）、中至剧烈体力活动时间（0.16[95%CI，0.03-0.29]小时）和平均向量幅度单位（每分钟 25[95%CI，0.1-49]计数）的变化方面具有有利影响。其他感兴趣的加速度计结果在组间无差异。
结论
在 DETERMINE 试验的这项探索性分析中，达格列净对心力衰竭患者整个左心室射血分数谱中选定的基于加速度计的体力活动测量指标具有有益影响，但正如之前报道的，并未改善 6 分钟步行距离。这些数据表明，基于加速度计的日常活动测量可能为 6 分钟步行距离提供补充信息，并确定了 6 分钟步行距离未检测到的治疗有益效果。
登记信息
网址：https://www.clinicaltrials.gov；唯一标识符：NCT03877237 和 NCT03877224。
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