The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure
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ORIGINAL RESEARCH ARTICLE
The AWAKE‑HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure Raj M. Khandwalla1 · Daniel Grant2 · Kade Birkeland3 · J. Thomas Heywood4 · Emmanuel Fombu5,8 · Robert L. Owens6 · Steven R. Steinhubl7 · for the AWAKE-H. F. Study Investigators Accepted: 3 September 2020 © Springer Nature Switzerland AG 2020
Abstract Background AWAKE-HF evaluated the effect of the initiation of sacubitril/valsartan versus enalapril on activity and sleep using actigraphy in patients who have heart failure with reduced ejection fraction (HFrEF). Methods In this randomized, double-blind study, patients with HFrEF (n = 140) were randomly assigned to sacubitril/ valsartan or enalapril for 8 weeks, followed by an 8-week open-label phase with sacubitril/valsartan. Primary endpoint was change from baseline in mean activity counts during the most active 30 min/day at week 8. The key secondary endpoint was change in mean nightly activity counts/minute from baseline to week 8. Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) was an exploratory endpoint. Results There were no detectable differences between groups in geometric mean ratio of activity counts during the most active 30 min/day at week 8 compared with baseline (0.9456 [sacubitril/valsartan:enalapril]; 95% confidence interval [CI] 0.8863–1.0088; P = 0.0895) or in mean change from baseline in activity during sleep (difference: 2.038 counts/min; 95% CI − 0.062 to 4.138; P = 0.0570). Change from baseline to week 8 in KCCQ-23 was 2.89 for sacubitril/valsartan and 4.19 for enalapril, both nonsignificant. Conclusions In AWAKE-HF, no detectable differences in activity and sleep were observed when comparing sacubitril/ valsartan with enalapril in patients with HFrEF using a wearable biosensor. Clinical trial registration ClinicalTrials.gov, NCT02970669. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40256-020-00440-y) contains supplementary material, which is available to authorized users. * Raj M. Khandwalla [email protected] Daniel Grant [email protected] Kade Birkeland [email protected] J. Thomas Heywood [email protected] Emmanuel Fombu [email protected] Robert L. Owens [email protected] Steven R. Steinhubl [email protected] 1
Department of Cardiology, Cedars‑Sinai Medical Care Foundation, Cedars-Sinai Heart Institute, 8501 Wilshire Ave, Beverly Hills, California 90211, United States
2
Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ 07936, USA
3
Department of Cardiology, Cedars‑Sinai, 127 S San Vicente Blvd a3600, Los Angeles, CA 90048, USA
4
Division of Cardiovascular Medicine, Scripps Clinic, 10666 N Torrey Pines Rd, San Diego, CA 92037, USA
5
Previously Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
6
Division of Pulmonary, Critical Care, and Sleep Medicine, San Diego School of Medicine, University of California, 4520 Executive Drive, San Diego, CA 92121, USA
7
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