Koehler F, et al. - In this Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial, researchers tested the effectiveness of remote patient management intervention on mortality and morbidity in a well defined heart failure population. According to the TIM-HF2 trial, a structured remote patient management intervention, when used in a well defined heart failure population, could decrease the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.

Methods

• This trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection.  
• The trial was done in Germany, and subjects were enrolled from hospitals and cardiology practices.
• Eligibility criteria included patients who 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 randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed).
• They excluded patients with major depression.
• After that, 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.
• Percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death was the primary outcome, analyzed in the full analysis set.
• All-cause and cardiovascular mortality were key secondary outcomes.

Results

• One thousand, five hundred seventy-one subjects were randomly assigned to remote patient management (n=796) or usual care (n=775) between Aug 13, 2013, and May 12, 2017.
• Out of 1571 subjects, 765 in the remote patient management group and 773 in the usual care group began their assigned care, and were incorporated into the full analysis set.
• It was observed that the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55–5·23) in the remote patient management group and 6·64% (6·19–7·13) in the usual care group (ratio 0·80, 95% CI 0·65–1·00; p=0·0460).
• Compared with 24·2 days (22·6–26·0) per year for patients assigned to usual care, patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6–19·1) per year.
• Compared with 11·34 (9·21–13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50–0·96; p=0·0280), the all-cause death rate was 7·86 (95% CI 6·14–10·10) per 100 person-years of follow-up in the remote patient management group.
• Between the two groups (HR 0·671, 95% CI 0·45–1·01; p=0·0560), cardiovascular mortality was not significantly different.