The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure

OUTSTEP‐HF: re‐evaluating the role of physical activity measures in drug and device development in heart failure

“…The neutral findings of OUTSTEP‐HF are similar to those reported recently with sacubitril/valsartan in the AWAKE‐HF trial using a different accelerometer‐based metric of physical activity 7 . Even if modest improvements in 6MWD in OUTSTEP‐HF were suggested, between‐group changes fell below traditionally accepted clinically meaningful thresholds for improvement.…”

Use of Actigraphy (Wearable Digital Sensors to Monitor Activity) in Heart Failure Randomized Clinical Trials: A Scoping Review

“…These studies were further screened for data pertinent to the role of actigraphy in HF trials. In total, 11 RCTs (n=1,455) met the prespecified inclusion and exclusion criteria and were included in the qualitative synthesis (Table 1) [8][9][10][11][12][13][14][15][16][17][18]. Full details of included trials are in Supplementary Table S2.…”

“…Some studies, however, demonstrated unexpected results. In the study by Redfield et al [15], it was found that in the group receiving the 120-mg dose of isosorbide mononitrate, as compared with the placebo group, there was a non-significant trend toward lower daily activity (−381 accelerometer units; 95% confidence Actigraphy-based endpoints of physical activity were aligned with the results of traditional HF endpoints in half of reported trials [8,12,15,18]. In three of the reported studies, actigraphy-based endpoints of physical activity differed from traditional HF outcomes on the results of the 6-MWT [11,17], brain natriuretic peptide [16] and quality of life measures [16].…”

“…Three trials in HF patients reported passive actigraphy-based measures for sleep quality as an outcome of interest [8][9][10]. These trials aimed to evaluate the effectiveness of autoservoventilation [9], cognitive-behavioral therapy [10] or pharmacologic therapy [8] (sacubitril/valsartan vs enalapril) for sleep apnea [9] and insomnia [8,10], respectively. The priority of the actigraphy-based endpoints for sleep varied considerably and were generally secondary trial objectives.…”

“…The priority of the actigraphy-based endpoints for sleep varied considerably and were generally secondary trial objectives. In the two studies by Khandwalla et al [8] and Redeker et al [10] that evaluated insomnia in HF, changes in sleep quality were assessed through actigraphy-measured mean nightly activity counts per minute (secondary endpoint) and the composite of sleep efficiency, sleep duration, sleep-onset latency, and time in bed (co-primary endpoint), respectively. In the trial evaluating sleep apnea by Hetzenecker et al [9], changes in sleep efficiency were assessed similarly through the actigraphy-measured composite of sleep-onset latency, sleep fragmentation, total sleep time, and time in bed (secondary post-hoc endpoint).…”