Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.

Summary

The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction.

Timeline

Start

2016-12-16

Primary completion

2018-03-19

Completion

2018-03-19

Outcome

Missed primary endpoint

paper 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 PMID 32978755 ↗

registry analysis (superiority test); Enalapril vs Sacubitril/Valsartan; p = 0.0895; Ratio of Geometric Means (SacVal/Ena) 0.9456 (95% CI 0.8863 to 1.0088); ANCOVA NCT02970669 ↗

Publications

• Khandwalla RM, Grant D, Birkeland K, Heywood JT, Fombu E, Owens RL, Steinhubl SR; AWAKE-H. F. Study Investigators. The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure. Am J Cardiovasc Drugs. 2021 Mar;21(2):241-254. doi: 10.1007/s40256-020-00440-y. Epub 2020 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Enalapril	Other / unclassified	2.5 mg	Oral
Comparator	Enalapril	Other / unclassified	10 mg	Oral
Subject	sacubitril/valsartan	Unknown	—	Oral

Indications