randOmized stUdy using acceleromeTry to compare Sacubitril/valsarTan and Enalapril in Patients with Heart Failure (OUTSTEP-HF)

Phase 1

• Conditions: Heart Failure with reduced ejection fraction (HFrEF); MedDRA version: 19.1 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003085-32-IS
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-13
• Study Completion: 2018-04-11
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 621

Inclusion Criteria

- Written informed consent obtained before any study assessment is performed.
- Ambulatory = 18 years of age with a diagnosis of chronic symptomatic HF (NYHA class = II) with reduced ejection fraction, defined as known LVEF = 40% AND one of the following two criteria:
- Plasma NT-proBNP level of = 300 pg/mL or BNP = 100 pg/mL (measurement may be recorded no longer than past 12 months) OR
- Confirmation of a heart failure hospitalization last 12 months.
- Patients must be on stable HF medication for at least 4 weeks prior to Week - 2, where the minimal daily dose of current evidence based therapies is equivalent to at least 2.5 mg/d enalapril
- Willingness to wear the accelerometer wristband continuously for the duration of the trial.
- Patients must be living in a setting, allowing them to move about freely and where they are primarily self responsible for scheduling their sleep and daily activities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

- History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes
- Use of sacubitril/valsartan prior to week - 2.
- Bedridden patients, or patients with significantly impaired/limited physical activity and/or fatigue due to medical conditions other than HF, such as, but not limited to angina (chest pain at exertion), arthritis, gout, peripheral artery occlusive disease, obstructive or restrictive lung disease, malignant disease, neurological disorders (e.g. Parkinson’s or Alzheimer’s disease, central and peripheral neuroinflammatory and degenerative disorders or functional central nervous lesions due to hemodynamic or traumatic incidents), injuries (incl. diabetic foot ulcers) or missing limbs
- Patients with palsy, tremor or rigor affecting the nondominant arm.
- Patients with any skin or other condition of the nondominant arm that would limit the ability to wear the actigraphy device continuously (24h/day) over 14 weeks.
- Patients fully depending on a mobility support system, e.g. wheelchair, scooter or walker. Patients are allowed to use a cane as long as this is not used with the non- dominant arm.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified