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

Galinier, Michel; Roubille, François; Berdague, Philippe; Brierre, Gilles; Cantie, Philippe; Dary, Patrick; Ferradou, Jean-Marc; Fondard, Olivier; Labarre, Jean Philippe; Mansourati, Jacques; Picard, François; Ricci, Jean-Etienne; Salvat, Muriel; Tartière, Lamia; Ruidavets, Jean-Bernard; Bongard, Vanina; Delval, Cécile; Lancman, Guila; Pasche, Hélène; Ramirez-Gil, Juan Fernando; Pathak, Atul

AIMS The aim was to assess the effect of a telemonitoring programme versus 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% CI 0.77-1.23; P = 0.80). In 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. This article is protected by copyright. All rights reserved.