HypertensionTrial design
Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial
- pragmatic, open-label, randomized parallel arm, international, multicenter clinical trial
Study context
- Population
- Adults with uncontrolled hypertension (systolic blood pressure (SBP) ≥ 140 mmHg)
- Planned comparison
- digital health intervention (DHI) based on the free Elfie solution compared to usual care
- Primary endpoint
- office SBP
- Follow-up
- 6 months
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial. Am Heart J. Published 10 February 2026. doi:10.1016/j.ahj.2026.107380
Summarised from the published abstract; every number is checked against it