Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
Condition: Heart Failure, Reduced Ejection Fraction
MeSH terms: Heart Failure; Heart Failure, Systolic
Intervention: sacubitril/valsartan (LCZ696); enalapril; matching placebo sacubitril/valsartan (LCZ696); matching placebo enalapril
Intervention description: sacubitril/valsartan tablet taken orally.; Enalapril tablet taken orally.; matching placebo sacubitril/valsartan tablet taken orally; matching placebo enalapril tablet taken orally
Intervention MeSH terms: Valsartan; Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Heart failure with reduced left ventricular ejection fraction (LVEF); Cardiac dysfunction; Heart muscle dysfunction; Left ventricular (LV) dilation; Left ventricular hypertrophy; HF; AHF; CHF; acute heart failure; chronic heart failure; congestive heart failure; congestive cardiac failure; Heart failure; HReEF; Physical Activity; Actigraphy; Home sleep test; wake

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.
    

Eligibility criteria:

        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