Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial
- PMID: 41679569
- DOI: 10.1016/j.ahj.2026.107380
Rationale and design of a pragmatic randomized clinical trial assessing a smartphone-based digital health intervention in hypertension: The ELFIE-HYPERTENSION trial
Abstract
Background: Hypertension represents a major contributor to the global cardiovascular (CV) disease burden, yet it remains inadequately controlled largely due to poor treatment adherence. Emerging digital health technologies hold promise for improving blood pressure (BP) management and CV outcomes, but the lack of evidence, unavailability in most countries, and out-of-pocket costs have hindered the widespread use of these technologies in clinical practice.
Objectives: To assess in a randomized controlled trial whether a digital health intervention (DHI) based on the free Elfie solution compared to usual care will reduce systolic blood pressure (SBP) in adults with uncontrolled hypertension (SBP ≥ 140 mmHg).
Methods: This is a pragmatic, open-label, randomized parallel arm, international, multicenter clinical trial. Adult individuals with hypertension are randomly assigned to usual care or a DHI based on the Elfie solution. Elfie offers a comprehensive set of features designed to enhance self-monitoring, adherence and education, complemented with a gamification feature to boost engagement. The primary outcome is office SBP measured at 6 months. Secondary outcomes include medication adherence, diastolic BP, BP control achievement, hypertension knowledge, self-care, health-related quality of life and process outcomes assessing app usage and engagement.
Conclusions: The ELFIE-HYPERTENSION trial is an international multicenter pragmatic randomized clinical trial, investigating the effects of an innovative, free and scalable DHI to improve BP control. If proven effective, this intervention can be easily and widely implemented in the management of hypertension in a variety of clinical settings globally.
Trial registration number: The trial is registered at the Clinicaltrials.gov (NCT06242483).
Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Conflict of interest EM reports conference support from Servier and Novo Nordisk; CT reports presenter fees from Novo Nordisk; LF reports no competing interests; FM reports no competing interests; JJM reports fees for consultancy or conference from Servier, Astra, Pfizer, Viatris, Isis Medical; KK has acted as a consultant, speaker, is supported or received grants for investigator-initiated studies from Abbott, Astra Zeneca, Bayer, Novo Nordisk, Sanofi-Aventis, Servier, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Oramed Pharmaceuticals, Pfizer, Roche, Daiichi-Sankyo, Applied Therapeutics, Embecta and Nestle Health Science, National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM), NIHR Global Research Centre for Multiple Long-Term Conditions, NIHR Cross NIHR Collaboration for Multiple Long-Term Conditions, NIHR Leicester Biomedical Research Centre (BRC) and the British Heart Foundation (BHF) Centre of Excellence; GS reports grants and personal fees from CSL Vifor, Boehringer Ingelheim, AstraZeneca, Servier, Novartis, Cytokinetics, Pharmacosmos, Medtronic, Bayer, and personal fees from Roche, Abbott, Edwards Lifescience, TEVA, Menarini, INTAS, GETZ, Hikma, and grants from Boston Scientific, Merck, all outside the submitted work; Dr Berwanger has received research grants from Bayer paid to his current institution and research grants from AstraZeneca, Bayer, Servier, Amgen, Pfizer, and Novartis paid to his former institution. KS reports conference support from Servier.
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