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Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.

Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.

Author information

1
Centre for Cardiovascular Telemedicine, Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany. Electronic address: friedrich.koehler@charite.de.
2
Centre for Cardiovascular Telemedicine, Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
3
Institute of Medical Biometry and Epidemiology, Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
4
Faculty of Epidemiology and Public Health, London School of Hygiene & Tropical Medicine, London, UK.
5
Clinic for Internal Medicine and Cardiology, Unfallkrankenhaus Berlin, Berlin, Germany.
6
Telemedicine Centre, Department of Cardiology, Municipal Hospital Brandenburg/Havel and Brandenburg Medical School, Brandenburg/Havel, Germany.
7
Cardiology Practice "Im Steiner Thor", Straubing, Germany.
8
Clinic for Internal Medicine, St Josefs-Krankenhaus Potsdam, Potsdam, Germany.
9
Department for Heart Insufficiency and Device Therapy, Albertinen Cardiovascular Centre, Hamburg, Germany.
10
Comprehensive Heart Failure Center (CHFC) Würzburg, University and University Hospital Würzburg, Würzburg, Germany.
11
Immanuel Hospital Bernau, Brandenburg Heart Center, Department of Cardiology and Medical School Brandenburg Theodor Fontane, Bernau, Germany.
12
Department of Cardiology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
13
Cardiology Practice, Bernau, Berlin, Germany.
14
Department of Internal Medicine I, Carl-von-Basedow-Klinikum Merseburg, Merseburg, Germany.
15
Department of Cardiology, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany; German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.
16
Federal Armed Forces Hospital Berlin, Division of Cardiology, Department of Internal Medicine, Berlin, Germany.
17
Municipal Hospital Dresden, Medical Department 2, Dresden, Germany.
18
Division of Cardiology, Angiology, Pneumology and Intensive Medical Care, Department of Internal Medicine I, Friedrich-Schiller-University Jena, University Hospital Jena, Jena, Germany.
19
Hannover Medical School, Department of Cardiology and Angiology, Hannover, Germany.
20
Department of Cardiology and Angiology, Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany.
21
Division of Cardiology and Metabolism, Department of Cardiology, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Berlin, Germany; German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany; University Medical Center Göttingen, Department of Cardiology and Pneumology, Göttingen, Germany.
22
Department of Cardiology and Angiology, Campus Mitte, Charité-Universitätsmedizin Berlin, Berlin, Germany; German Centre for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.

Abstract

BACKGROUND:

Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population.

METHODS:

The Telemedical Interventional Management in Heart Failure II (TIM-HF2) 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 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 randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 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, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed.

FINDINGS:

Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. 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). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6-19·1) per year compared with 24·2 days (22·6-26·0) per year for patients assigned to usual care. 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 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). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45-1·01; p=0·0560).

INTERPRETATION:

The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.

FUNDING:

German Federal Ministry of Education and Research.

PMID:
30153985
DOI:
10.1016/S0140-6736(18)31880-4
[Indexed for MEDLINE]

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