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Telemedicial Interventional Management in Heart Failure (TIM-HF II)

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Telemedical Interventional Management in Heart Failure II (TIM-HF2)

Chronic heart failure is a widespread disease that currently affects about 1.2 million patients in Germany. With approximately 450,000 hospitalizations in 2016, it represents the most frequent reason for hospitalization. The outcome of this is the enormous charging of costs for care on these patients from the health and care insurance providers which makes more than three billion euros p.a. (Statistisches Bundesamt 2017)

In a controlled, prospective, multicentre, randomized, controlled clinical trial TIM-HF II (NCT01878630, DRKS00010239) the non-inferiority of a new ambulatory care model for underdeveloped rural area without resident cardiologists in patients with chronic heart failure (CHF) compared to regions with practicing cardiologists regarding medical health and economic effectiveness will be tested.

Primary endpoint is "Percentage of days lost due to unplanned cardiovascular (CV) hospitalization or due to death for any reason during the individual follow-up time”.

1,538 patients were recruited from metropolitan areas with more than 200,000 inhabitants and/or with a medical University and in rural areas in Germany.

Following results have been published yet:

Primary results:

Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, 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 SM, Schulze CP, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.

Telemedicine 24/7

Winkler S, Koehler K, Prescher S, Koehler M, Kirwan BA, Tajsic M, Koehler F. Is 24/7 remote patient management in heart failure necessary? Results of the telemedical emergency service used in the TIM-HF and in the TIM-HF2 trialsESC Heart Fail. 2021 Jun 28. doi: 10.1002/ehf2.13413. Online ahead of print.
 

Telemedizin and Atrial Fibrillation

Stegmann T, Koehler K, Wachter R, Moeller V, ZeynalovaN S, Koehler F*, Laufs S*. 
Heart failure patients with atrial fibrillation benefit from remote patient management: insights from the TIM-HF2 trial. ESC Heart Fail. 2020 Oct; 7(5): 2516-26
 

Telemedizin and Stroke/TIA

Tütüncü S, Honold M, Koehler K, Deckwart D, Koehler F*, Haeusler KG*. 
Non-Invasive Telemedical-Care in Heart Failure Patients and Stroke – Post-hoc-analysis of TIM-HF and TIM-HF2 trials, ESC Heart Fail. 2020 Jun; 7(3): 884-91.
 

Effects 12 months after end of intervention:

Koehler F, Koehler K, Prescher S, Kirwan BA, Wegscheider K, Vettorazzi E, Lezius S, Winkler S, Moeller V, Fiss G, Schleder J, Koehler M, Zugck C, Störk S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl S, Halle M, von Haehling S, Dreger H, Stangl K, Deckwart O, Anker SD. 
Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial; The Lancet Digital Health 2020 Jan; 2(1):pe16-e24.

Telemedizin and Biomarker:

Möckel M, Koehler K, Anker SD, Vollert J, Moeller V, Koehler M, Gehrig S, Wiemer JC, van Heahling S, Koehler F.  Biomarker Guidance Allows a More Personalized Allocation of Patients for Remote Patient Management in Heart Failure - Results from the TIM-HF2 Trial, Eur J Heart Fail. 2019 Nov;21(11):1445-1458.

inclusion criteria

  • chronic heart failure New York Heart Association (NYHA) class II or III
  • echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
  • hospitalization due to decompensated HF within the last 12months before randomization
  • informed consent

exclusion criteria

  • Hospitalization within the last 7 days before randomization
  • Implanted cardiac assist system
  • Acute coronary syndrome within the last 7 days before randomization
  • High urgent listed for heart transplantation (HTx)
  • Planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
  • Revascularization and/or CRT-implantation within 28 days before randomization
  • Known alcohol or drug abuse
  • Terminal renal insufficiency with hemodialysis
  • Impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
  • Existence of any disease reducing life expectancy to less than 1 year
  • Age < 18 years
  • Pregnancy
  • Participation in other treatment studies or remote patient management programmes (register studies possible)

Principal Investigator: Prof. Dr. Friedrich Koehler, MD

First clinical results

Primary Outcome: Patients of the RPM Group lost less days due to unplanned cardiovascular hospitalisation or all-cause death in contrast to the Usual Care Group (RPM: 17,8 days; Usual Care: 24,2 days; p=0.046).

Secondary outcomes: Also the all-cause mortality was significant reduced (RPM: 8 days, Usual Care: 11 days, p:0.028). For unplanned hospitalisation due to heart failure patients of the RPM Group lost 3.8 days per year while patients of the Usual Care Group lost  5.6 days per year (p=0.007).

 

Relevance for Clinical Practice

The TIM-HF2 trial results indicate that, in a well-defined HF population followed for 12 months, a holistic RPM approach reduces:

  1. Days lost due to unplanned CV hospitalisations and all-cause death
  2. Total mortality and
  3. Days lost due to unplanned HF hospitalisations.


A well structured Telemedical Centre, providing 24/7 service, is a key element within the RPM intervention.

The subgroup analysis suggests that RPM is an effective approach to overcome regional differences in HF Management.

 

Study Design:

Koehler F, Koehler K, Deckwart O et al. Telemedical Interventional Management in Heart Failure II (TIM-HF 2), a randomised, controlled Trial investigating the impact of telemedicine on unplanned cardiovascular hospitalisations and mortality in heart failure patients: study design and description of the intervention, Eur J Heart Fail, 2018, doi:10.1002/ejhf.1300