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

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 0·35 [95% CI 0·24-0·50]; p<0·0001; 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. FUNDING: The HERMeS trial was funded by an unrestricted grant from Novartis.