Activity Sensors to Evaluate the Effect of Sacubitril/Valsartan on Quality‐of‐Life in Heart Failure: rational and design of the AWAKE‐HF study

• Published in: ESC Heart Failure Vol. 6; no. 6; pp. 1313 - 1321
• Main Authors: Khandwalla, Raj M., Birkeland, Kade, Heywood, J. Thomas, Steinhubl, Steven, McCague, Kevin, Fombu, Emmanuel, Grant, Daniel, Riebman, Jerome B., Owens, Robert L.
• Format: Journal Article
• Language: English
• Published: England John Wiley & Sons, Inc 01.12.2019; John Wiley and Sons Inc; Wiley
• Subjects: Accelerometry; Adolescent; Adult; Aged; Aged, 80 and over; Aminobutyrates - therapeutic use; Angiotensin Receptor Antagonists - therapeutic use; Biosensor; Blood pressure; Drug Combinations; Drug dosages; Ejection fraction; Enzymes; Exercise; FDA approval; Female; Health‐related quality of life; Heart failure; Heart Failure - drug therapy; Heart Failure - physiopathology; Humans; Male; Middle Aged; Monitoring, Physiologic; Patients; Physical activity; Potassium; Quality of Life; Sacubitril/valsartan; Sleep; Study Design; Study Designs; Tetrazoles - therapeutic use; Young Adult; New York; United States > US; Heart failure; Health-related quality of life; Sacubitril/valsartan; Sleep; Physical activity; Biosensor
• ISSN: 2055-5822; 2055-5822
• DOI: 10.1002/ehf2.12514

Aims Limited data are available regarding the ability of sacubitril/valsartan to provide clinically meaningful health‐related quality of life (HRQoL) improvements among individuals with heart failure (HF). Objective measurement of physical activity and sleep using actigraphy can provide insight into daily functioning and HRQoL. Methods and results We designed an 18 week, multicenter, randomized, double‐blind, double‐dummy, parallel‐group study to objectively assess changes in function and HRQoL directly after initiating sacubitril/valsartan vs. enalapril in participants with HF in their home environments. A total of 136 outpatient, ambulatory participants with New York Heart Association Class II or III HF with reduced ejection fraction (HFrEF) will be included in the study. Patients will undergo a 2 week baseline observational phase (continuing current HF treatment); data from the second week of this phase will be the baseline value for comparison with those of subsequent periods. Patients will then enter an 8 week blinded‐treatment phase (randomly assigned 1:1 to sacubitril/valsartan or enalapril), followed by an 8 week open‐label extension phase (treatment with only sacubitril/valsartan). The primary efficacy endpoint is the change in mean activity counts during the most active 30 min of the participant's day between baseline and the final randomized treatment phase measurement. Secondary endpoints include the change in mean sleep activity during the randomized and open‐label phases; questionnaires will also assess HRQoL measures. Rather than analysing pooled actigraphy data, the researchers are considering each participant to be acting as his or her own control. Conclusions This will be the first study to assess the effects of sacubitril/valsartan on objective measures of sleep and activity in individuals with HFrEF within the context of their daily lives. Wearable accelerometer devices will be used to gain insight into how the medication affects physical activity and sleep.