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

Heart Failure, Reduced Ejection Fraction Clinical Trial

— AWAKE-HF  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970669
• Other study ID #: CLCZ696BUS14
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2016
• Est. completion date: March 19, 2018

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 19, 2018
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• Written informed consent must be obtained before any assessment is performed.

• Men and women between 18 and 80 years of age

• Subjects diagnosed with NYHA class II or III heart failure and with reduced ejection (HFrEF).

(Reduced ejection is defined as left ventricular EF = 40%. LVEF =40% may be determined via any local measurement within the past 6 months prior to signing consent, using echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular angiography provided no subsequent study documenting an EF of >40%. If the EF measurement is expressed as a value range, the average of the range endpoint values should be used as the EF).

• Subjects must be a candidate for treatment with sacubitril/valsartan as per USPI.

• Subjects must be living in a traditional residence, apartment, or non-communal adult home where they can move about freely and frequently and are primarily responsible for scheduling their sleep and daily activities.

Key Exclusion Criteria:

• Subjects with a history of hypersensitivity to any of the study drugs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.

• Subjects with a history of angioedema drug related or otherwise

• Subjects with symptomatic hypotension or systolic blood pressure <100 mmHg at screening or <95 mmHg at randomization

• Subjects with any conditions in skin or upper extremities which would limit the ability to tolerate a wrist-worn actigraphy device on the non-dominant arm for 24 hours/day for the duration of the study.

• Subjects who are non-ambulatory or use mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable.

• Subjects with physical activity impairment primarily due to conditions other than heart failure such as:

• Exertional angina inflammatory or degenerative joint disease -gout

• peripheral vascular disease

• neurologic disease affecting activity or mobility

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Reduced Ejection Fraction

Intervention

Drug:
• sacubitril/valsartan (LCZ696)
sacubitril/valsartan tablet taken orally.
• enalapril
Enalapril tablet taken orally.
• matching placebo sacubitril/valsartan (LCZ696)
matching placebo sacubitril/valsartan tablet taken orally
• matching placebo enalapril
matching placebo enalapril tablet taken orally

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Allen	Texas
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Columbia	South Carolina
United States	Novartis Investigative Site	Doral	Florida
United States	Novartis Investigative Site	East Brunswick	New Jersey
United States	Novartis Investigative Site	Fort Payne	Alabama
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Inverness	Florida
United States	Novartis Investigative Site	Lancaster	South Carolina
United States	Novartis Investigative Site	Lutherville	Maryland
United States	Novartis Investigative Site	McKinney	Texas
United States	Novartis Investigative Site	Midlothian	Virginia
United States	Novartis Investigative Site	New Braunfels	Texas
United States	Novartis Investigative Site	Ormond Beach	Florida
United States	Novartis Investigative Site	Port Orange	Florida
United States	Novartis Investigative Site	Ridgewood	New Jersey
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Marcos	Texas
United States	Novartis Investigative Site	Sherman	Texas
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Tacoma	Washington
United States	Novartis Investigative Site	Tomball	Texas
United States	Novartis Investigative Site	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, week 8
Secondary	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).	Baseline, Week 1
Secondary	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).	Baseline (Sacubitril/Valsartan: week -1/ Enalapril: week 8), week 9 and 16
Secondary	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).	Baseline, Week 8
Secondary	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).	Baseline, Week 1
Secondary	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).	Baseline (Sacubitril/Valsartan: week -1 / Enalapril: week 8), week 9 and 16

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com