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Completed

NCT Number: NCT02970669

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

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.

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Key information

Conditions

Heart Failure, Reduced Ejection Fraction Behavior Cardiomegaly Cardiovascular Diseases Dilatation, Pathologic Heart Diseases Heart Failure Heart Failure, Systolic Hypertrophy Hypertrophy, Left Ventricular Motor Activity Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Fort Payne, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacubitril/valsartan (LCZ696)

Drug

sacubitril/valsartan tablet taken orally.

Enalapril

Drug

Enalapril tablet taken orally.

matching placebo sacubitril/valsartan (LCZ696)

Drug

matching placebo sacubitril/valsartan tablet taken orally

matching placebo enalapril

Drug

matching placebo enalapril tablet taken orally

Primary outcomes

  1. Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subject's Day Between Week 8 and Baseline

    Time frame: Baseline, week 8

    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.

Secondary outcomes

  1. Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 1

    Time frame: Baseline, 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).

  2. Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 9 and 16

    Time frame: Baseline (Sacubitril/Valsartan: week -1/ Enalapril: week 8), 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).

  3. Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 8

    Time frame: Baseline, 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).

  4. Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 1

    Time frame: Baseline, 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).

  5. Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 9 and 16

    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 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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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).

Acronym: AWAKE-HF

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 22, 2016
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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