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on behalf of the Telemedical Interventional Monitoring in Heart Failure InvestigatorsBackground-This study was designed to determine whether physician-led remote telemedical management (RTM) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure (HF). Methods and Results-We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction Յ35% and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction Յ25%. Patients were randomly assigned (1:1) to RTM or usual care. Remote telemedical management used portable devices for ECG, blood pressure, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers. The primary end point was death from any cause. The first secondary end point was a composite of cardiovascular death and hospitalization for HF. Baseline characteristics were similar between the RTM (nϭ354) and control (nϭ356)

AimsRemote patient management (telemonitoring) may help to detect early signs of cardiac decompensation, allowing optimization of and adherence to treatments in chronic heart failure (CHF). Two meta-analyses have suggested that telemedicine in CHF can reduce mortality by 30-35%. The aim of the TIM-HF study was to investigate the impact of telemedical management on mortality in ambulatory CHF patients. MethodsCHF patients [New York Heart Association (NYHA) II/III, left ventricular ejection fraction (LVEF) ≤35%] with a history of cardiac decompensation with hospitalization in the past or therapy with intravenous diuretics in the prior 24 months (no decompensation required if LVEF ≤ 25%) were randomized 1:1 to an intervention group of daily remote device monitoring (electrocardiogram, blood pressure, body weight) coupled with medical telephone support or to usual care led by the patients' local physician. In the intervention group, 24/7 physician-led medical support was provided by two central telemedical centres. A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization. The primary endpoint was total mortality. The first secondary endpoint was a composite of cardiovascular mortality or hospitalization due to heart failure. Other secondary endpoints included cardiovascular mortality, all-cause and cause-specific hospitalizations (all time to first event) as well as days lost due to heart failure hospitalization or cardiovascular death (in % of follow-up time), and changes in quality of life and NYHA class. Overall, 710 CHF patients were recruited. The mean follow-up was 21.5 + 7.2 months, with a minimum of 12 months. Perspective

ClinicalTrials.gov Identifier NCT01878630.

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Aims Depression is a frequent comorbidity in patients with chronic heart failure (CHF). Telemonitoring has emerged as a novel option in CHF care. However, patients with depression have been excluded in most telemedicine studies. This pre‐specified subgroup analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM‐HF) trial investigates the effect of telemonitoring on depressive symptoms over a period of 12 months. Methods and results The TIM‐HF study randomly assigned 710 patients with CHF to either usual care (UC) or a telemedical intervention (TM) using non‐invasive devices for daily monitoring electrocardiogram, blood pressure and body weight. Depression was evaluated by the 9‐item Patient Health Questionnaire (PHQ‐9) with scores ≥10 defining clinically relevant depressive symptoms. Mixed model repeated measures were performed to calculate changes in PHQ‐9 score. Quality of life was measured by the Short Form‐36. At baseline, 156 patients had a PHQ‐9 score ≥10 points (TM: 79, UC: 77) with a mean of 13.2 points indicating moderate depressiveness. Patients randomized to telemedicine showed an improvement of their PHQ‐9 scores, whereas UC patients remained constant (P = 0.004). Quality of life parameters were improved in the TM group compared to UC. Adjustment was performed for follow‐up, New York Heart Association class, medication, age, current living status, number of hospitalizations within the last 12 months and serum creatinine. In the study population without depression, the PHQ‐9 score was similar at baseline and follow‐up. Conclusion Telemedical care improved depressive symptoms and had a positive influence on quality of life in patients with CHF and moderate depression.

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Background The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial showed that, compared with usual care, a structured remote patient management (RPM) intervention done over 12-months reduced the percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause death. The aim of the study was to evaluate whether this clinical benefit seen for the RPM group during the initial 12 month follow-up of the TIM-HF2 trial would be sustained 1 year after stopping the RPM intervention.Methods TIM-HF2 was a prospective, randomised, multicentre trial done in 43 hospitals, 60 cardiology practices, and 87 general practitioners in Germany. Patients with heart failure, New York Heart Association functional class II or III, and who had been hospitalised for heart failure within 12 months before randomisation were randomly assigned to either the RPM intervention or usual care. At the final study visit (main trial), the RPM intervention was stopped and the 1 year extended follow-up period started, which lasted 1 year. The primary outcome was percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause mortality. Analyses were done using the intention-totreat principle. This trial is registered with ClinicalTrials.gov, number NCT01878630.