Clinical trial NCT01878630: Telemedical Interventional Management in Heart Failure II
Official title: Telemedical Interventional Management in Heart Failure II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
CHF
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: University of Leipzig
First posted: 2013-06-17
Enrollment: 1571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Primary purpose: TREATMENT

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

Detailed description: The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

Eligibility criteria: 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
* Depression score PHQ-9: \<10

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)

Primary outcomes:
measure: Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
timeFrame: 12 months/ individual-patient follow-up time.
Secondary outcomes:
measure: All-cause mortality during the individual patient follow-up time.
timeFrame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
measure: Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
timeFrame: 12 months/ individual follow-up time
measure: Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time
timeFrame: 12 months/ individual follow-up time
measure: Change in MLHFQ-questionnaire overall score between baseline and 365 days
timeFrame: 12 months/ individual follow-up time
measure: Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.
timeFrame: 12 months/ individual follow-up time
Other outcomes:
measure: Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days.
timeFrame: 12 months (baseline and final visit)
measure: Change from baseline in biomarkers (MR-proADM, NT-proBNP, MR-proANP, PCT) stratified by LVEF (>45 vs ≤ 45) at 365 days.
timeFrame: 12 months (baseline and final visit)
measure: Unplanned cardiovascular hospitalisations and cardiovascular mortality.
timeFrame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
measure: Unplanned cardiovascular hospitalisations and all-cause mortality.
timeFrame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
measure: Unplanned heart failure hospitalisations and cardiovascular mortality.
timeFrame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
measure: Unplanned heart failure hospitalisations and all-cause mortality.
timeFrame: 12 month
measure: Cost-utility Analysis.
timeFrame: 12 month/individual follow-up time
measure: Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation
timeFrame: 12 months
Locations:
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg - Medizinische Klinik I
city: Angermünde
country: Germany
facility: GLG Fachklinik Wolletzsee GmbH
city: Bad Belzig
country: Germany
facility: Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie
city: Beeskow
country: Germany
facility: Oder-Spree-Krankenhaus Beeskow GmbH
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Bundeswehr Krankenhaus
city: Berlin
country: Germany
facility: Cardio Centrum Berlin GmbH
city: Berlin
country: Germany
facility: DRK Kliniken Berlin-Köpenick
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin
city: Berlin
country: Germany
facility: Gemeinschaftspraxis am Bayerischen Platz
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH
city: Berlin
country: Germany
facility: Herzpraxis Berlin
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin
city: Berlin
country: Germany
facility: Kardiologie Weissensee
city: Berlin
country: Germany
facility: Kardiologische Praxis im Spreebogen
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede e. V.
city: Berlin
country: Germany
facility: Kranoldpraxis
city: Berlin
country: Germany
facility: Martin-Luther Krankenhaus
city: Berlin
country: Germany
facility: MVZ Treffpunkt Geißenweide GmbH
city: Berlin
country: Germany
facility: Polikum Institut GmbH Polikum Friede
city: Berlin
country: Germany
facility: Praxis am Dachsbau
city: Berlin
country: Germany
facility: Praxis Claus
city: Berlin
country: Germany
facility: Praxis Dres. Weinrich
city: Berlin
country: Germany
facility: Praxis Frank
city: Berlin
country: Germany
facility: Praxis Pinkwart
city: Berlin
country: Germany
facility: Praxis Roeder
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Hellersdorf
city: Berlin
country: Germany
facility: Vivantes MVZ Wedding
city: Berlin
country: Germany
facility: Ärzte Schönhauser Berlin e.V.
city: Bernau
country: Germany
facility: Brandenburgklinik Berlin-Brandenburg GmbH
city: Bernau
country: Germany
facility: Immanuel Klinikum Bernau, Herzzentrum Brandenburg
city: Bernau
country: Germany
facility: Kardiologische Praxis Gola
city: Bitterfeld-Wolfen
country: Germany
facility: Gemeinschaftspraxis Hampel/Janoske
city: Bitterfeld-Wolfen
country: Germany
facility: Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor
city: Brandenburg/Havel
country: Germany
facility: Städtisches Klinikum Brandenburg/Havel
city: Celle
country: Germany
facility: Herz - und Gefäßzentrum am Neumarkt
city: Chemnitz
country: Germany
facility: Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus
city: Detmold
country: Germany
facility: Klinikum Lippe - Kardiologie
city: Dresden
country: Germany
facility: Cardiologicum Dresden & Pirna
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden-Friedrichstadt
city: Ebersberg
country: Germany
facility: Kreisklinik Ebersberg gGmbH
city: Eberswalde
country: Germany
facility: Klinikum Barnim GmbH, Werner Forßmann Krankenhaus
city: Elsterwerda
country: Germany
facility: Praxis Hagenow
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang Goethe-Universität
city: Gera
country: Germany
facility: Praxis Langel
city: Gerlingen
country: Germany
facility: Kardiologische Praxis Dr. Wehr
city: Gifhorn
country: Germany
facility: Cardiocampus - Kardiologische Gemeinschaftspraxis
city: Gotha
country: Germany
facility: Praxis Dr. med. Frank Warzok
city: Gräfenhainichen
country: Germany
facility: Praxis Karsten Müller
city: Gräfenhainichen
country: Germany
facility: Praxis Dr. med Karsten Müller
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kleinmachnow
country: Germany
facility: Kardiologie im Praxishaus
city: Königs-Wusterhausen
country: Germany
facility: Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus
city: Köthen (Anhalt)
country: Germany
facility: HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin
city: Langen
country: Germany
facility: Asklepios Klinik Langen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie
city: Ludwigsburg
country: Germany
facility: Cardio Centrum Ludwigsburg Bietigheim
city: Lübbenau
country: Germany
facility: MVZ Lübbenau GmbH
city: Magdeburg
country: Germany
facility: Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf
city: Malchin
country: Germany
facility: Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4
city: Manschnow
country: Germany
facility: Praxis Horn
city: Marbach
country: Germany
facility: Praxis Dr. med. Dieter Böhm
city: Markkleeberg
country: Germany
facility: Praxis Dr. Jens Taggeselle
city: Merseburg
country: Germany
facility: Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg
city: Merzig
country: Germany
facility: Kardiologische Praxis Dr. Rheinert
city: Mühldorf Am Inn
country: Germany
facility: Kardiologie Mühldorf am Inn
city: Nauen
country: Germany
facility: Kardiologische Praxis Nauen
city: Neubrandenburg
country: Germany
facility: Dietrich Bonhoeffer Klinikum
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
city: Oranienburg
country: Germany
facility: Kardiologische Praxis Dr. H.P. Mieg
city: Oschatz
country: Germany
facility: Praxis Donaubauer
city: Pasewalk
country: Germany
facility: Internist; Facharzt für Innere Medizin
city: Perleberg
country: Germany
facility: Kreiskrankenhaus Prignitz gGmbH
city: Pirna
country: Germany
facility: Cardiologicum
city: Potsdam
country: Germany
facility: St. Josefs-Krankenhaus Potsdam-Sanssouci
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
city: Potsdam
country: Germany
facility: Poliklinik Ernst von Bergmann GmbH
city: Pritzwalk
country: Germany
facility: Praxis Ehlert
city: Riesa
country: Germany
facility: Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
city: Riesa
country: Germany
facility: Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
city: Rostock
country: Germany
facility: Kardiologische Praxis Dr. Placke
city: Rüdersdorf
country: Germany
facility: Facharzt-Zentrum Pneumologie und Kardiologie
city: Rüdersdorf
country: Germany
facility: Klinik am See/REHA-Fachklinik für Innere Medizin
city: Saalfeld/Saale
country: Germany
facility: Praxis für Kardiologie
city: Saalfeld/Saale
country: Germany
facility: Thüringen-Kliniken "Georgius Agricola"
city: Schneeberg
country: Germany
facility: Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie
city: Schopfheim
country: Germany
facility: Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim
city: Schwedt/Oder
country: Germany
facility: Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH
city: Seelow
country: Germany
facility: Praxis für Kardiologie
city: Senftenberg
country: Germany
facility: Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal GmbH
city: Straubing
country: Germany
facility: Internistische Gemeinschaftspraxis Steiner Thor
city: Straubing
country: Germany
facility: Klinikum St. Elisabeth Straubing GmbH
city: Strausberg
country: Germany
facility: Internistische Praxis am Landsberger Tor
city: Strausberg
country: Germany
facility: Kardiologische Facharztpraxis Dr. med. Heike Olthoff
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus Stuttgart
city: Templin
country: Germany
facility: Sana-Kliniken Berlin-Brandenburg GmbH
city: Wittenberg
country: Germany
facility: Kardiologische Gemeinschaftspraxis Wittenberg
city: Wittstock
country: Germany
facility: Praxis Stiller
city: Wolfsburg
country: Germany
facility: Ambulantes Herz-Kreislauf Zentrum Wolfsburg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zeuthen
country: Germany
facility: Praxis Lägel
Study officials:
affiliation: Charité - Universitaetsmedizin Berlin
name: Friedrich Koehler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Koehler 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.
citation: Anker 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.
citation: Cowie 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.
citation: Prescher 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.
citation: 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, 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.
citation: Koehler 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.
citation: 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, 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.