Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial
Open accessAbstract
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.
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The TEMA-HF1 and TIM-HF-2 trials showed that telemonitoring reduced days lost owing to heart failure hospitalizations and reduced all-cause mortality.
“The TEMA-HF1 and TIM-HF-2 trial showed that telemonitoring reduced days lost owing to HF hospitalizations and reduced all-cause mortality66,67”
From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [66]
In the TIM-HF2 trial, the intervention was associated with a smaller proportion of days lost from unplanned HF-related hospital admissions and lower all-cause mortality (HR 0.70, 95% CI 0.50-0.96).
“The intervention, compared with usual care, was associated with a smaller proportion of days lost from unplanned HF-related hospital admissions and had a lower all-cause mortality (HR 0.70, 95% CI 0.50–0.96) after 393 days of follow-up66.”
From Smart wearable devices in cardiovascular care: Where we are and how to move forward (2021) · cites this paper as [66]
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- Authors
- Koehler, F., Koehler, K., Deckwart, O., Prescher, S., Wegscheider, K., Kirwan, B.-A., Winkler, S., Vettorazzi, E., Bruch, L., Oeff, M., Zugck, C., Doerr, G., Naegele, H., Störk, S., Butter, C., Sechtem, U., Angermann, C., Gola, G., Prondzinsky, R., Edelmann, F., Spethmann, S., Schellong, S. M., Schulze, P. C., Bauersachs, J., Wellge, B., Schoebel, C., Tajsic, M., Dreger, H., Anker, S. D., & Stangl, K.
- Affiliations
- Charité – Universitätsmedizin Berlin (DE)
- University Medical Center Hamburg-Eppendorf (DE)
- London School of Hygiene & Tropical Medicine (GB)
- Unfallkrankenhaus Berlin (DE)
- Universitätsklinikum Brandenburg an der Havel (DE)
- University of Würzburg (DE)
- Medizinische Hochschule Brandenburg Theodor Fontane (DE)
- Robert Bosch Hospital (DE)
- German Centre for Cardiovascular Research (DE)
- Bundeswehr (DE)
- Städtisches Klinikum Dresden (DE)
- Jena University Hospital (DE)
- Medizinische Hochschule Hannover (DE)
- Universitätsmedizin Göttingen (DE)
- Corresponding author
- Koehler, Friedrich
- ORCID
- Koehler, Friedrich
- Deckwart, Oliver
- Prescher, Sandra
- Wegscheider, Karl
- Kirwan, Bridget-Anne
- Winkler, Sebastian
- Vettorazzi, Eik
- Bruch, Leonhard
- Störk, Stefan
- Butter, Christian
- Sechtem, Udo
- Angermann, Christiane
- Edelmann, Frank
- Spethmann, Sebastian
- Schellong, Sebastian M
- Schulze, P Christian
- Bauersachs, Johann
- Dreger, Henryk
- Anker, Stefan D
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2018-09
- Volume
- 392
- Issue
- 10152
- Pages
- 1047-1057
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2888540279
- Cited by
- 739
- References
- 22
- Citations by year
- 2026: 102 · 2025: 89 · 2024: 81 · 2023: 84 · 2022: 90 · 2021: 125 · 2020: 97 · 2019: 60 · 2018: 11
- FWCI
- 55.34
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (acceptedVersion)
- PubMed (publishedVersion)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, other-oa)
- Funders
- Deutsches Zentrum für Luft- und Raumfahrt
- Bundesamt für Sozialversicherungen
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- heart failure, remote patient care, telemedicine, heart failure decompensation, emergency admissions, all-cause mortality, cardiovascular mortality, left ventricular ejection fraction, hospital readmission, usual care, pragmatic trial design, pragmatic interpretation
- MeSH terms
- Aged, Aged, 80 and over, Female, Heart Failure, Hospitalization, Humans, Male, Prospective Studies, Surveys and Questionnaires, Telemedicine, Quality-Adjusted Life Years, Kaplan-Meier Estimate
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