Telemonitoring versus standard of care in heart failure: a randomised multicentre trial.

Aims The aim was to assess the effect of a telemonitoring programme vs. standard care (SC) in preventing all-cause deaths or unplanned hospitalisations in heart failure (HF) at 18 months. Methods and results OSICAT was a randomised, multicentre, open-label French study in 937 patients hospitalised for acute HF <= 12 months before inclusion. Patients were randomised to telemonitoring (daily body weight measurement, daily recording of HF symptoms, and personalised education) (n = 482) or to SC (n = 455). Mean +/- standard deviation number of events for the primary outcome was 1.30 +/- 1.85 for telemonitoring and 1.46 +/- 1.98 for SC [rate ratio 0.97, 95% confidence interval (CI) 0.77-1.23;P = 0.80]. In New York Heart Association (NYHA) class III or IV HF, median time to all-cause death or first unplanned hospitalisation was 82 days in the telemonitoring group and 67 days in the SC group (P = 0.03). After adjustment for known predictive factors, telemonitoring was associated with a 21% relative risk reduction in first unplanned hospitalisation for HF [hazard ratio (HR) 0.79, 95% CI 0.62-0.99;P = 0.044); the relative risk reduction was 29% in patients with NYHA class III or IV HF (HR 0.71, 95% CI 0.53-0.95;P = 0.02), 38% in socially isolated patients (HR 0.62, 95% CI 0.39-0.98;P = 0.043), and 37% in patients who were >= 70% adherent to body weight measurement (HR 0.63, 95% CI 0.45-0.88;P = 0.006). Conclusion Telemonitoring did not result in a significantly lower rate of all-cause deaths or unplanned hospitalisations in HF patients. The pre-specified subgroup results suggest the telemonitoring approach improves clinical outcomes in selected populations but need further confirmation.