Telemedical Interventional Management in Heart Failure II
TIM-HF2
1 other identifier
interventional
1,571
1 country
109
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2013
Longer than P75 for phase_3
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedStudy Start
First participant enrolled
August 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2018
CompletedAugust 3, 2018
August 1, 2018
3.8 years
June 12, 2013
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.
12 months/ individual-patient follow-up time.
Secondary Outcomes (5)
All-cause mortality during the individual patient follow-up time.
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
12 months/ individual follow-up time
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time
12 months/ individual follow-up time
Change in MLHFQ-questionnaire overall score between baseline and 365 days
12 months/ individual follow-up time
Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.
12 months/ individual follow-up time
Other Outcomes (8)
Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days.
12 months (baseline and final visit)
Change from baseline in biomarkers (MR-proADM, NT-proBNP, MR-proANP, PCT) stratified by LVEF (>45 vs ≤ 45) at 365 days.
12 months (baseline and final visit)
Unplanned cardiovascular hospitalisations and cardiovascular mortality.
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
- +5 more other outcomes
Study Arms (2)
Remote Patient Management
EXPERIMENTALintervention group
Usual Care
ACTIVE COMPARATORcontrol group
Interventions
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) plus devices for Remote Patient Management at patient site for daily monitoring of ECG, weight, blood pressure, self-report of health status: * weighing scale (Seca 861 with bluetooth, seca gmbh \& co. kg.) * blood pressure device (UA767PBT with bluetooth, A\&D Ltd.) * ECG-eventrecorder (PhysioMem® PM 1000, getemed Medizin- und Informationstechnik AG) * patient-communication platform (Physio-Gate® PG 1000, getemed Medizin- und Informationstechnik AG) * help call device (DORO Easy 510/ Doro HandlePlus 334gsm, doro AB) at center site: \- electronic patient record (eHealth connect 2.0, T-Systems International)
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
Eligibility Criteria
You may qualify if:
- 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
- Depression score PHQ-9: \<10
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- German Federal Ministry of Education and Researchcollaborator
- University of Leipzigcollaborator
Study Sites (109)
Klinikum St. Marien Amberg - Medizinische Klinik I
Amberg, Germany
GLG Fachklinik Wolletzsee GmbH
Angermünde, Germany
Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie
Bad Belzig, 14805, Germany
Oder-Spree-Krankenhaus Beeskow GmbH
Beeskow, Germany
Charité - Universitaetsmedizin Berlin
Berlin, 10117, Germany
Bundeswehr Krankenhaus
Berlin, Germany
Cardio Centrum Berlin GmbH
Berlin, Germany
DRK Kliniken Berlin-Köpenick
Berlin, Germany
Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin
Berlin, Germany
Gemeinschaftspraxis am Bayerischen Platz
Berlin, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH
Berlin, Germany
Herzpraxis Berlin
Berlin, Germany
Jüdisches Krankenhaus Berlin
Berlin, Germany
Kardiologie Weissensee
Berlin, Germany
Kardiologische Praxis im Spreebogen
Berlin, Germany
Krankenhaus Waldfriede e. V.
Berlin, Germany
Kranoldpraxis
Berlin, Germany
Martin-Luther Krankenhaus
Berlin, Germany
MVZ Treffpunkt Geißenweide GmbH
Berlin, Germany
Polikum Institut GmbH Polikum Friede
Berlin, Germany
Praxis am Dachsbau
Berlin, Germany
Praxis Claus
Berlin, Germany
Praxis Dres. Weinrich
Berlin, Germany
Praxis Frank
Berlin, Germany
Praxis Pinkwart
Berlin, Germany
Praxis Roeder
Berlin, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
Vivantes Klinikum Hellersdorf
Berlin, Germany
Vivantes MVZ Wedding
Berlin, Germany
Ärzte Schönhauser Berlin e.V.
Berlin, Germany
Brandenburgklinik Berlin-Brandenburg GmbH
Bernau, Germany
Immanuel Klinikum Bernau, Herzzentrum Brandenburg
Bernau, Germany
Kardiologische Praxis Gola
Bernau, Germany
Gemeinschaftspraxis Hampel/Janoske
Bitterfeld-Wolfen, Germany
Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor
Bitterfeld-Wolfen, Germany
Städtisches Klinikum Brandenburg/Havel
Brandenburg/Havel, Germany
Herz - und Gefäßzentrum am Neumarkt
Celle, Germany
Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH
Chemnitz, 09111, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Carl-Thiem-Klinikum Cottbus
Cottbus, Germany
Klinikum Lippe - Kardiologie
Detmold, Germany
Cardiologicum Dresden & Pirna
Dresden, Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, Germany
Kreisklinik Ebersberg gGmbH
Ebersberg, 85560, Germany
Klinikum Barnim GmbH, Werner Forßmann Krankenhaus
Eberswalde, Germany
Praxis Hagenow
Elsterwerda, Germany
Klinikum der Johann-Wolfgang Goethe-Universität
Frankfurt am Main, Germany
Praxis Langel
Gera, Germany
Kardiologische Praxis Dr. Wehr
Gerlingen, 70839, Germany
Cardiocampus - Kardiologische Gemeinschaftspraxis
Gifhorn, Germany
Praxis Dr. med. Frank Warzok
Gotha, 99867, Germany
Praxis Karsten Müller
Gräfenhainichen, 06773, Germany
Praxis Dr. med Karsten Müller
Gräfenhainichen, Germany
Universitätsklinikum Halle (Saale)
Halle, 06120, Germany
Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH
Hamburg, Germany
Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin
Hanover, Germany
Universitätsklinikum Jena
Jena, Germany
Kardiologie im Praxishaus
Kleinmachnow, Germany
Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus
Königs Wusterhausen, Germany
HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin
Köthen, Germany
Asklepios Klinik Langen
Langen, Germany
Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie
Leipzig, Germany
MVZ Lübbenau GmbH
Lubnjow, Germany
Cardio Centrum Ludwigsburg Bietigheim
Ludwigsburg, Germany
Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf
Magdeburg, Germany
Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4
Malchin, 17139, Germany
Praxis Horn
Manschnow, Germany
Praxis Dr. med. Dieter Böhm
Marbach, 71672, Germany
Praxis Dr. Jens Taggeselle
Markkleeberg, 04416, Germany
Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg
Merseburg, Germany
Kardiologische Praxis Dr. Rheinert
Merzig, 66663, Germany
Kardiologie Mühldorf am Inn
Mühldorf, Germany
Kardiologische Praxis Nauen
Nauen, Germany
Dietrich Bonhoeffer Klinikum
Neubrandenburg, Germany
Ruppiner Kliniken GmbH
Neuruppin, Germany
Kardiologische Praxis Dr. H.P. Mieg
Oranienburg, Germany
Praxis Donaubauer
Oschatz, Germany
Internist; Facharzt für Innere Medizin
Pasewalk, Germany
Kreiskrankenhaus Prignitz gGmbH
Perleberg, Germany
Cardiologicum
Pirna, Germany
St. Josefs-Krankenhaus Potsdam-Sanssouci
Potsdam, 14471, Germany
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, Germany
Poliklinik Ernst von Bergmann GmbH
Potsdam, Germany
Praxis Ehlert
Pritzwalk, Germany
Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
Riesa, 01587, Germany
Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
Riesa, Germany
Kardiologische Praxis Dr. Placke
Rostock, Germany
Facharzt-Zentrum Pneumologie und Kardiologie
Rüdersdorf, Germany
Klinik am See/REHA-Fachklinik für Innere Medizin
Rüdersdorf, Germany
Praxis für Kardiologie
Saalfeld, Germany
Thüringen-Kliniken "Georgius Agricola"
Saalfeld, Germany
Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie
Schneeberg, Germany
Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim
Schopfheim, 79650, Germany
Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH
Schwedt, Germany
Praxis für Kardiologie
Seelow, Germany
Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg
Senftenberg, Germany
Johanniter-Krankenhaus Genthin-Stendal GmbH
Stendal, 39576, Germany
Internistische Gemeinschaftspraxis Steiner Thor
Straubing, Germany
Klinikum St. Elisabeth Straubing GmbH
Straubing, Germany
Internistische Praxis am Landsberger Tor
Strausberg, Germany
Kardiologische Facharztpraxis Dr. med. Heike Olthoff
Strausberg, Germany
Robert Bosch Krankenhaus Stuttgart
Stuttgart, Germany
Sana-Kliniken Berlin-Brandenburg GmbH
Templin, Germany
Kardiologische Gemeinschaftspraxis Wittenberg
Wittenberg, Germany
Praxis Stiller
Wittstock, Germany
Ambulantes Herz-Kreislauf Zentrum Wolfsburg
Wolfsburg, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Praxis Lägel
Zeuthen, Germany
Related Publications (12)
Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, de Brouwer S, Perrin E, Baumann G, Gelbrich G, Boll H, Honold M, Koehler K, Kirwan BA, Anker SD. Telemedicine in heart failure: pre-specified and exploratory subgroup analyses from the TIM-HF trial. Int J Cardiol. 2012 Nov 29;161(3):143-50. doi: 10.1016/j.ijcard.2011.09.007. Epub 2011 Oct 8.
PMID: 21982700BACKGROUNDKoehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.
PMID: 21444883BACKGROUNDAnker SD, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet. 2011 Aug 20;378(9792):731-9. doi: 10.1016/S0140-6736(11)61229-4.
PMID: 21856487BACKGROUNDCowie MR, Bax J, Bruining N, Cleland JG, Koehler F, Malik M, Pinto F, van der Velde E, Vardas P. e-Health: a position statement of the European Society of Cardiology. Eur Heart J. 2016 Jan 1;37(1):63-6. doi: 10.1093/eurheartj/ehv416. Epub 2015 Aug 24. No abstract available.
PMID: 26303835BACKGROUNDKerwagen F, Stork S, Koehler K, Vettorazzi E, Bauser M, Zernikow J, Barzen G, Hiddemann M, Groschel J, Gross M, Melzer C, Stangl K, Hindricks G, Koehler F, Winkler S, Spethmann S. Rurality, travel distance, and effectiveness of remote patient management in patients with heart failure in the TIM-HF2 trial in Germany: a pre-specified analysis of an open-label, randomised controlled trial. Lancet Reg Health Eur. 2025 May 18;54:101321. doi: 10.1016/j.lanepe.2025.101321. eCollection 2025 Jul.
PMID: 40672055DERIVEDKoehler F, Koehler J, Bramlage P, Vettorazzi E, Wegscheider K, Lezius S, Spethmann S, Iakoubov R, Vijayan A, Winkler S, Melzer C, Schutt K, Dessapt-Baradez C, Paar WD, Koehler K, Muller-Wieland D. Impact of telemedical management on hospitalization and mortality in heart failure patients with diabetes: a post-hoc subgroup analysis of the TIM-HF2 trial. Cardiovasc Diabetol. 2024 Jun 12;23(1):198. doi: 10.1186/s12933-024-02285-0.
PMID: 38867198DERIVEDKerwagen F, Koehler K, Vettorazzi E, Stangl V, Koehler M, Halle M, Koehler F, Stork S. Remote patient management of heart failure across the ejection fraction spectrum: A pre-specified analysis of the TIM-HF2 trial. Eur J Heart Fail. 2023 Sep;25(9):1671-1681. doi: 10.1002/ejhf.2948. Epub 2023 Jul 31.
PMID: 37368507DERIVEDDeckwart O, Koehler K, Lezius S, Prescher S, Koehler F, Winkler S. Effects of remote patient management on self-care behaviour in heart failure patients: results from the randomized TIM-HF2 trial. Eur J Cardiovasc Nurs. 2023 Dec 14;22(8):786-794. doi: 10.1093/eurjcn/zvad019.
PMID: 36752782DERIVEDPrescher S, Winkler S, Riehle L, Hiddemann M, Moeller V, Collins C, Deckwart O, Spethmann S. Patient reported experience and adherence to remote patient management in chronic heart failure patients: a posthoc analysis of the TIM-HF2 trial. Eur J Cardiovasc Nurs. 2023 Apr 12;22(3):245-253. doi: 10.1093/eurjcn/zvac080.
PMID: 36062451DERIVEDKoehler 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, Stork S, Butter C, Prondzinsky R, Spethmann S, Angermann C, Stangl V, 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. Lancet Digit Health. 2020 Jan;2(1):e16-e24. doi: 10.1016/S2589-7500(19)30195-5. Epub 2019 Dec 12.
PMID: 33328035DERIVEDKoehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Winkler S, Vettorazzi E, Polze A, Stangl K, Hartmann O, Marx A, Neuhaus P, Scherf M, Kirwan BA, Anker SD. 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. Eur J Heart Fail. 2018 Oct;20(10):1485-1493. doi: 10.1002/ejhf.1300. Epub 2018 Sep 19.
PMID: 30230666DERIVEDKoehler 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, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, 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.
PMID: 30153985DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Friedrich Koehler, Prof. Dr.
Charité - Universitaetsmedizin Berlin
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Friedrich Koehler, MD, Senior Physician
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 17, 2013
Study Start
August 8, 2013
Primary Completion
May 12, 2017
Study Completion
May 17, 2018
Last Updated
August 3, 2018
Record last verified: 2018-08