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

Telemonitoring has emerged as a promising alternative to conventional heart failure (HF) management, but randomized trials show conflicting results, and data from high-risk populations with frailty, is scarce. The Individually Tailored monitoring at home after HEART failure (IT-HEART) trial evaluates whether a non-invasive multi-component telemonitoring program improves outcomes in HF patients after HF-hospitalization. The aim of this study is to describe flow of patients and baseline characteristics of the IT-HEART trial population. This multicenter, open-label, blinded-endpoint trial randomized HF patients to either written information and a standardized self-treatment plan (Control) or HF education, a personalized self-treatment plan, and three months of home telemonitoring (Intervention). The primary endpoint is the total number of HF hospitalizations or cardiovascular death. Of 1016 consecutively screened patients, 200 (19.7%) were randomized. At baseline, median age was 78 (IQR 70–83) years, and 29.5% were women. Participants were multimorbid (median 6 diagnoses) with a median Clinical Frailty Scale score 4 (IQR 4–5). Median score of the European Heart Failure Self-care Behaviour Scale was 53 (IQR 35–67), and 75.5% had inadequate self-care. Self-rated knowledge on HF management was 3 (IQR 0–7) on a 0–10 Likert scale. Only 35.5% (n = 71) weighed themselves weekly whereas 1% (n = 2) reported having a self-care plan. In conclusion, patients enrolled after a recurrent HF hospitalization were multimorbid and frail, and scored low on self‑care and health literacy. The IT-HEART intervention is targeted to these factors and has the potential to improve clinical and patient‑reported outcomes, and costs.