Methods:

The TIM-HF2 (Telemedical Interventional Management in Heart Failure II) trial investigators conducted a prospective, randomized, controlled, parallel-group, unmasked, multicenter trial, with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomization, and had a left ventricular ejection fraction (LVEF) of ≤45% (or if >45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only, and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analyzed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. All survival analyses were done on a time-to-first event basis. Cumulative incidence curves for all-cause mortality were constructed according to the Kaplan-Meier method, and the differences between curves were examined by the log-rank statistic.