randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure
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).
Timeline
- Start
- 2016-12-20
- Primary completion
- 2018-04-11
- Completion
- 2018-04-11
Outcome
Missed primary endpoint
registry analysis (other test); LCZ696 (Sacubitril/Valsartan) vs Enalapril; p = 0.2464; Differences of least square means 5.68 (95% CI -3.93 to 15.29) NCT02900378 ↗
registry analysis (other test); LCZ696 (Sacubitril/Valsartan) vs Enalapril; p = 0.4769; Differences of least square means -6.14 (97.5% CI -25.70 to 13.41) NCT02900378 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enalapril | Other / unclassified | 10 mg | — |
| Subject | LCZ696 | Unknown | 24 mg | — |
| Subject | LCZ696 | Unknown | 26 mg | — |
| Subject | LCZ696 | Unknown | 49 mg | — |
| Subject | LCZ696 | Unknown | 51 mg | — |
| Subject | LCZ696 | Unknown | 97 mg | — |
| Subject | LCZ696 | Unknown | 103 mg | — |