Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-03-01 @ 8:55 PM
Study NCT ID:
NCT02970669
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2016-11-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study and 8-week Open Label Extension to Evaluate the Effect of Initiation of Sacubitril/Valsartan on Objective Measures of Waking Activity and Sleep, as Health-related Quality of Life Functions in Subjects With Heart Failure and Reduced Ejection Fraction (AWAKE-HF).
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT02389933
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
AWAKE-HF
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: