TIM-HF2 Trial: Morbidity and Mortality Benefit of Remote Telemedical Interventional Management In Heart Failure No Longer Observed 1 Year After End of Trial​ Extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial

Mandana Chitsazan, M.D.
By Mandana Chitsazan, M.D. on

The positive effect of the remote patient management (RPM) intervention on morbidity and mortality, seen in the Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was no longer observed 1 year after stopping the RPM intervention. The extended follow-up results of the TIM-HF2 trial led by Dr. Koehler (Department of Cardiology and Angiology, Centre for Cardiovascular Telemedicine, Charité–Universitätsmedizin Berlin, Berlin, Germany) was recently published in the Lancet.

Over the past decade, many studies have investigated the effect of remote patient management (RPM) on morbidity and mortality in patients with heart failure. The Heart Failure Society of America (2018) stated that routine use of external devices for telemonitoring is not recommended. The Heart Failure Association of the European Society of Cardiology suggested that home telemonitoring similar to the approach used in TIM-HF2 trial could be considered for patients with heart failure.

The TIM-HF2 trial was a prospective, randomized, multicenter trial conducted in Germany. Eligible heart failure patients were randomly assigned to either the RPM group or the usual care group. RPM intervention included a daily remote transmission of the patient’s weight, systolic and diastolic blood pressure, heart rate, heart rhythm analysis for 2 min, three-channel electrocardiogram, peripheral capillary oxygen saturation (SpO2), and a self-rated health status (scale range 1–5) to the Telemedicine Centre (TMC) using non-invasive telemonitoring devices. Patients were followed for one year. TIM-HF2 trial showed benefits on morbidity and mortality when using a holistic RMP intervention combined with patient education and continuous TMC support. At the end of the TIM-HF2 trial, RPM intervention was stopped and data collection continued for an additional 12 months (ie, extended follow-up) in a real-world setting. The primary outcome was the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.

The next step for research on non-invasive RPM-interventions is to investigate the interventions applicability with respect to duration of the intervention and the management of the transmitted data in a real-world setting. This process of upscaling will certainly affect personnel and financial resources. Therefore, it is important to identify the patients with heart failure that are most likely to benefit from a non-invasive RPM intervention and to individualize the management of the transmitted data with the support of artificial intelligence”. Dr. Koehler et.al.

A total of 1538 patients were enrolled to the main trial Between Aug 12013 and May 2017 (765 to the RPM group and 773 to the usual care group) in the main trial. Among those, 671 patients in the RPM group and 673 patients in the usual care group entered the extended follow-up period for an additional 12 months. In the extended follow-up period, the primary outcome, i.e. the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality did not differ significantly between two groups: weighted mean 5·95% [95% CI 4·59–7·31] in the RPM group compared with 6·64% [95% CI 5·19–8·08] in the usual care group [rate ratio 0·79; 95% CI 0·78–1·21]).

According to the investigators, the extended follow-up study was under-powered to detect significant differences for the primary outcome. Therefore, further research is needed to confirm the findings.

Leave a Reply