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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
140
sacubitril/valsartan tablet taken orally.
Enalapril tablet taken orally.
matching placebo sacubitril/valsartan tablet taken orally
Novartis Investigative Site
Fort Payne, Alabama, United States
Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subject's Day Between Week 8 and Baseline
The primary endpoint is the ratio in mean activity counts collected during the most active 30 minutes of the subject's day between the final randomized treatment phase measurement (mean of endpoint data collected each day during week 8) and baseline phase (mean of endpoint data collected each day during week -1), as measured by wrist-worn accelerometer collected actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day). A ratio \> 1 indicates an increase in mean activity counts from baseline to week 8.
Time frame: Baseline, week 8
Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 1
Change in mean activity counts during most active 30 minutes of day from baseline phase (mean of data collected during week -1) to week 1 (mean of data collected during week 1), as measured by actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day).
Time frame: Baseline, Week 1
Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 9 and 16
Change in mean activity counts during most active 30 minutes of day from baseline phase (mean of data collected during week -1 for Sacubitril/Valsartan and mean of data collected during week 8 for Enalapril) to week 9 and 16 (mean of data collected during weeks 9 and 16), as measured by actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day).
Time frame: Baseline (Sacubitril/Valsartan: week -1/ Enalapril: week 8), week 9 and 16
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 8
Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1) to the final randomized treatment phase measurement (mean of data collected during week 8), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).
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matching placebo enalapril tablet taken orally
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Stockton, California, United States
Novartis Investigative Site
West Hills, California, United States
Novartis Investigative Site
Doral, Florida, United States
Novartis Investigative Site
Inverness, Florida, United States
Novartis Investigative Site
Ormond Beach, Florida, United States
Novartis Investigative Site
Port Orange, Florida, United States
Novartis Investigative Site
Lutherville, Maryland, United States
Novartis Investigative Site
East Brunswick, New Jersey, United States
...and 13 more locations
Time frame: Baseline, Week 8
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 1
Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1) to week 1 (mean of data collected during week 1), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).
Time frame: Baseline, Week 1
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 9 and 16
Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1 for Sacubitril/Valsartan and mean of data collected during week 8 for Enalapril) to week 9 and 16 (mean of data collected during week 9 and 16), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).
Time frame: Baseline (Sacubitril/Valsartan: week -1 / Enalapril: week 8), week 9 and 16