NCT01878630: TIM-HF2

Telemedical Interventional Management in Heart Failure II

Completed Phase 3 Last updated 3 August 2018

What this trial tests

Phase 3 trial testing Remote Patient Management in Chronic Heart Failure in 1,571 participants. Completed in 17 May 2018.

Timeline

8 August 2013

Primary endpoint
12 May 2017

17 May 2018

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,571
Start date	8 August 2013
Primary completion	12 May 2017
Estimated completion	17 May 2018
Sites	109 locations across Germany

Drugs / interventions tested

• Remote Patient Management
• Usual Care

Conditions studied

• Chronic Heart Failure — all drugs for Chronic Heart Failure →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Chronic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:

* days lost due to unplanned cardiovascular hospitalization or death
* all-cause mortality
* cardiovascular mortality
* quality of life

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.
   Koehler F, Koehler K, Deckwart O, Prescher S, et al · · 2018 · cited 466× · PMID 30153985 · DOI 10.1016/s0140-6736(18)31880-4
2. Disease management interventions for heart failure.
   Takeda A, Martin N, Taylor RS, Taylor SJ. · · 2019 · cited 91× · PMID 30620776 · DOI 10.1002/14651858.cd002752.pub4
3. Telemedical Interventional Management in Heart Failure II (TIM-HF2), 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.
   Koehler F, Koehler K, Deckwart O, Prescher S, et al · · 2018 · cited 79× · PMID 30230666 · DOI 10.1002/ejhf.1300
4. 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.
   Koehler F, Koehler K, Prescher S, Kirwan BA, et al · · 2020 · cited 34× · PMID 33328035 · DOI 10.1016/s2589-7500(19)30195-5
5. 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 trials.
   Winkler S, Koehler K, Prescher S, Koehler M, et al · · 2021 · cited 17× · PMID 34182596 · DOI 10.1002/ehf2.13413
6. Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial.
   Kerwagen F, Koehler K, Vettorazzi E, Stangl V, et al · · 2023 · cited 14× · PMID 37368507 · DOI 10.1002/ejhf.2948
7. Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial.
   Sydow H, Prescher S, Koehler F, Koehler K, et al · · 2022 · cited 14× · PMID 34894273 · DOI 10.1007/s00392-021-01980-2
8. Short-Term Therapies for Treatment of Acute and Advanced Heart Failure-Why so Few Drugs Available in Clinical Use, Why Even Fewer in the Pipeline?
   Pollesello P, Ben Gal T, Bettex D, Cerny V, et al · · 2019 · cited 14× · PMID 31683969 · DOI 10.3390/jcm8111834