He@rt - Connected to health: new models and technologies for heart failure patient assistance
Project Objectives
"HE@RT: connected to health" aims to develop and apply a prototype technology for supporting physicians in the early identification of decompensation in patients affected by Heart Failure (HF). The objective is to demonstrate, through the implementation of a telemonitoring system, that it is possible to detect warning signs of decompensation. HE@RT has developed a home telemonitoring system that will be commercially available in 12 months. The trial involves the recruitment of 47 telemonitored HF patients, and 43 HF patients recruited as a "control group" and monitored according to the traditional care models.
The project was conducted as a randomized clinical trial with parallel groups that included HF patients aged 65 + years, discharged from an intensive care ward or a Day Hospital of the Policlinico Universitario Campus Biomedico. Patients were assigned to the treatment group (telemonitoring of oxygen saturation, heart rate, blood pressure, plus telephone support, N=47) or standard care group (N=43). The composite outcome included a combination of all-cause mortality and hospital admission. The mean age of the sample was 80, and the mean ejection fraction was 46%. The two groups were similar, except for a higher prevalence of women and disability in the control group.
The mortality/hospitalization rate was 42% in the control group and 21% in the experimental group (relative risk: 0.508, confidence interval [CI] 95%: 0.264-0.977). Similar results were obtained taking into account the ward from which patients had been discharged (intensive care ward vs. Day Hospital), gender and disability (Hazard Ratio: 0.419, 95% CI: 0.187-0.937).
Start/End date
July 2012 - July 2014
Principal Investigator
Prof. Raffaele Antonelli Incalzi
Host Institution
Intersistemi Italia, with the collaboration of Evolvo, a member of this group, which is qualified in the innovation and development of telemedicine and digital health solutions.
Other Institutions involved
- AGE Consulting
- Consorzio Roma Ricerche
Source of funding
Finanziaria Lazio per lo Sviluppo (FILAS)