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

• DOI: 10.1016/j.landig.2025.02.006
• Publication Date: 2025-05-14T10:07:26Z
• Authors: Sergi Yun; Josep Comín-Colet; Esther Calero-Molina; Encarnación Hidalgo; Núria José-Bazán; Marta Cobo Marcos; Teresa Soria; Pau Llàcer; Cristina Fernández; José Manuel Garcí...; Concepción Cruzado; Álvaro González-F...; Eva María García-...; José Luis Morales...; Cristina Solé; Elena García-Romero; Julio Núñez; José Civera; Coral Fernández; Mercedes Faraudo; Pedro Moliner; Francesc Formiga; Javier de-Juan Ba...; Isabel Zegri-Reiriz; José María Verdú-...; Emili Vela; David Monterde; Jordi Piera-Jiménez; Gerard Carot-Sans; Cristina Enjuanes; Santiago Jiménez-...; Alberto Garay; Raúl Ramos-Polo; Alexandra Pons-Ri...; Herminio Morillas; Sílvia Jovells-Vaqué; Marta Tajes; Rafael de la Espr...; Elisa Esther Rodr...; Jessica Paola Rug...; Maria del Carmen ...; Carla Castillo; Ainhoa Robles-Mezcua; Ramon Bascompte; Paola Macarena Be...; Rocío Rodríguez; Román Freixa Pamias; Olga Guri; Cristina Delso Ga...; Sònia Sarret Vila; Angelique-Casas T...; Jordi Fernández

The potential of mobile health (mHealth) technology combining telemonitoring and teleintervention as a non-invasive intervention to reduce the risk cardiovascular events in patients with heart failure during early post-discharge period (ie, vulnerable phase) has not been evaluated our knowledge. We investigated efficacy incorporating mHealth into routine management vulnerable-phase patients. Heart Failure Events Reduction Remote Monitoring eHealth Support (HERMeS) trial was 24-week, randomised, controlled, open-label masked endpoint adjudication, phase 3 conducted ten centres (hospitals [n=9] primary care service [n=1]) experienced Spain. enrolled adults (aged ≥18 years) diagnosed according 2016 European Society Cardiology criteria (then-current clinical practice guidelines at initiation trial) who had recently discharged (within preceding 30 days enrolment) from hospital admission that due decompensation, or were process discharge planning. After discharge, participants centrally randomly assigned (1:1) via web-based system mHealth, comprising preplanned structured health-care follow-up videoconference, usual each centre's framework including nurse-led educational programme. outcome composite occurrence death worsening 6-month period, assessed by time-to-first-event analysis full set intention-to-treat principle. No prospective systematic collection harms information planned. HERMeS is registered ClinicalTrials.gov, NCT03663907, completed. From May 15, 2018, April 4, 2022, 506 (207 [41%] women 299 [59%] men) assigned: 255 251 care. mean age 73 years (SD 13). Follow-up ended prematurely 51 (20%) group 36 (14%) group. During group, event occurred 43 (17%) participants, compared 102 (41%) (hazard ratio for time first 0·35 [95% CI 0·24-0·50]; p<0·0001; relative reduction 65% 50-76]). spontaneously reported either follow-up. mHealth-based reduced new fatal non-fatal people recent decompensation. current findings could help improve transitional encouraging integration guidelines. funded an unrestricted grant Novartis.