Heart failure
Conditions
Interventions
Treatment with LCZ696 (sacubitril/valsartan) or enalapril.
Actigraphy
Chronic heartfailure
Sacubitril/valsartan
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Change from baseline in 6-minute walking test. - To assess changes in daily non-sedentary daytime activity between baseline and after 12 weeks of treatment in sacubitril/valsartan vs. enalapril treated patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients with improved performance (* 30m in the 6MWT between sacubitril/valsartan vs. enalapril (wks 0 to 12). To demonstrate that sacubitril/valsartan is superior in improving exercise capacity as assessed by 6MWT at wk 12 in a subset of patients with baseline 6min walk distance equal to or less than 300 meters and in between 100-450 meters To compare the effects of sacubitril/valsartan vs. enalapril on patients symptom progression by means of the Patient Global Assessment (PGA) questionnaire at week 4, week 8 and week12. To assess dynamics of changes from baseline1 in daily non-sedentary daytime physical activity in sacubitril/valsartan vs. enalapril treated patients in weekly and two-weekly intervals. To assess changes from baseline 1 in mean daily non-sedentary daytime physical activity classified by its intensity for sacubitril/valsartan vs. enalapril treated patients after week 4, week 8 and week12. To assess the difference in non-sedentary daytime physical activity between sacubitril/valsartan vs. enalapril treated patients during the treatment period (weeks 0-12). To assess changes from baseline1 on M6min (an actigraphy-based measure of the peak six minutes of daytime physical activity) in sacubitril/valsartan vs. enalapril treated patients after week 4; week 8 and week 12. To assess changes from baseline (week 0) in exercise capacity assessed by means of the 6-minute walking test at weeks 4, 8 and 12. | — |
Countries
The Netherlands
Outcome results
None listed