At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years, ambulatory, diagnosed with chronic symptomatic heart failure NYHA class ≥II with reduced ejection fraction (LVEF ≤40%)
- ✓Either plasma NT-proBNP ≥300 pg/mL or BNP ≥100 pg/mL (within past 12 months) OR heart failure hospitalization in last 12 months
- ✓On stable heart failure medication for ≥4 weeks prior to screening, with minimal daily dose equivalent to ≥2.5 mg/day enalapril
- ✓Willing to wear the accelerometer wristband continuously for the duration of the trial
- ✕Prior use of sacubitril/valsartan
- ✕Bedridden patients or those with significantly impaired/limited physical activity due to medical conditions other than heart failure, including angina, arthritis, gout, peripheral artery occlusive disease, obstructive or restrictive lung disease, malignant disease, neurological disorders, or injuries
- ✕Palsy, tremor, or rigor affecting the non-dominant arm
- ✕Skin or other condition of the non-dominant arm limiting ability to wear the actigraphy device continuously for 14 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Prospective, Randomized, Double-blind Study to Assess the Impact of Sacubitril/Valsartan vs. Enalapril on Daily Physical Activity Using a Wrist Worn Actigraphy Device in Adult Chronic Heart Failure Patients
In Brief
A Phase 3 clinical trial evaluating LCZ696 (Sacubitril/Valsartan), Placebo of LCZ696 (Sacubitril/Valsartan), and 2 other interventions for Chronic Heart Failure With Reduced Ejection Fraction. Completed, enrolled 621 participants across 119 sites in 19 countries.
Detailed Summary
The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).
Study Details
Timeline
Interventions
LCZ696 (sacubitril/valsartan) was available in 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets
Placebo of LCZ696 (sacubitril/valsartan) was available to match 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets
Enalapril was available in 2.5 mg, 5 mg and 10 mg film-coated tablets
Placebo of Enalapril was available to match 2.5 mg, 5 mg and 10 mg film-coated tablets