Individually Tailored monitoring at home after hospitalization for HEART failure (IT-HEART): Design and baseline characteristics of a randomized clinical trial

Abstract Background Telemonitoring has emerged as a promising alternative to conventional heart failure (HF) management. Despite its potential, evidence from randomized controlled trials remains inconclusive, and data from high-risk populations with frailty, is scarce. The Individually Tailored remote monitoring at home after HEART failure (IT-HEART) trial evaluates whether a non-invasive telemonitoring program improves clinical, patient reported, and health economic outcomes in HF patients after a recurrent hospitalization. Purpose To describe flow of patients and baseline characteristics of the IT-HEART study population. Methods This multicentre, open-label, blinded-endpoint trial randomized HF patients to either written information and a self-management plan (Control) or HF education, a personalized self-management plan, and three months of home telemonitoring (Intervention). The primary endpoint is the total number of HF hospitalizations or cardiovascular death. Secondary endpoints include hospitalizations and outpatient visits, adherence the intervention, patient reported outcomes, and health economic measures. End of follow-up will be in October 2026. Results Of 1027 consecutively screened patients, 200 (19.5%) were randomized. Median age was 78 (IQR (70-83) years, and 29.5% were women. At baseline, participants had substantial multimorbidity with median Clinical Frailty Scale score 4, median Charlson Comorbidity Index score 6, and symptom burden was high (Table). Median self-rated HF management knowledge was 3 (IQR 0-7) on a 0-10 Likert scale. Only 35.5% weighed themselves weekly whereas 1 % (n=2) reported having a formal self-care plan at baseline. In the intervention arm (N=100), 64 participants used a digital telemonitoring platform and 36 received telephone-based monitoring. Conclusion Patients enrolled after a recurrent HF hospitalization were older, multimorbid, and frail, with high symptom burden, and low self-care and health literacy. The IT-HEART telemonitoring intervention is targeted to these modifiable deficits and has the potential to improve clinical and patient-reported outcomes.For image description, please refer to the figure legend and surrounding text.