Evaluation of mobile health technology combining telemonitoring and teleintervention versus usual care in vulnerable-phase heart failure management (HERMeS): a multicentre, randomised controlled trial

Abstract

Background The potential of mobile health (mHealth) technology combining telemonitoring and teleintervention as a non-invasive intervention to reduce the risk of cardiovascular events in patients with heart failure during the early post-discharge period (ie, the vulnerable phase) has not been evaluated to our knowledge. We investigated the efficacy of incorporating mHealth into routine heart failure management in vulnerable-phase patients. Methods The Heart Failure Events Reduction with Remote Monitoring and eHealth Support (HERMeS) trial was a 24-week, randomised, controlled, open-label with masked endpoint adjudication, phase 3 trial conducted in ten centres (hospitals [n=9] and a primary care service [n=1]) experienced in heart failure management in Spain. We enrolled adults (aged >= 18 years) with heart failure diagnosed according to the 2016 European Society of Cardiology criteria (then-current clinical practice guidelines at the initiation of the trial) who had recently been discharged (within the preceding 30 days of enrolment) from a hospital admission that was due to heart failure decompensation, or who were in the process of discharge planning. After discharge, participants were centrally randomly assigned (1:1) via a web-based system to mHealth, comprising telemonitoring and preplanned structured health-care follow-up via videoconference, or usual care according to each centre's heart failure care framework including a nurse-led educational programme. The primary outcome was a composite of the occurrence of cardiovascular death or worsening heart failure events during the 6-month follow-up period, assessed by time-to-first-event analysis in the full analysis set by the intention-to-treat principle. No prospective systematic collection of harms information was planned. The HERMeS trial is registered with ClinicalTrials.gov, NCT03663907, and is completed. Findings From May 15, 2018, to April 4, 2022, 506 participants (207 [41%] women and 299 [59%] men) were randomly assigned: 255 to mHealth and 251 to usual care. The mean age of participants was 73 years (SD 13). Follow-up ended prematurely in 51 (20%) of 255 participants in the mHealth group and 36 (14%) of 251 in the usual care group. During follow-up in the mHealth group, cardiovascular death or a worsening heart failure event occurred in 43 (17%) of 255 participants, compared with 102 (41%) of 251 in the usual care group (hazard ratio for time to first event 035 [95% CI 024-050]; p<00001; relative risk reduction 65% [95% CI 50-76]). No spontaneously reported harms were reported in either group during follow-up. Interpretation mHealth-based heart failure care combining teleintervention and telemonitoring reduced the risk of new fatal and non-fatal cardiovascular events compared with usual care in people with a recent hospital admission due to heart failure decompensation. The current findings could help to improve the care of patients with heart failure in the transitional post-discharge period by encouraging integration of mHealth into clinical practice guidelines. Copyright (c) 2025 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).