Telemedical Interventional Management in Heart Failure II

Chronic Heart Failure Clinical Trial

— TIM-HF2  

Official title:

Telemedical Interventional Management in Heart Failure II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878630
• Other study ID #: 13KQ0904B
• Status: Completed
• Phase: Phase 3
• Start date: August 8, 2013
• Est. completion date: May 17, 2018

Study information

• Verified date: August 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1571
• Est. completion date: May 17, 2018
• Est. primary completion date: May 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Remote Patient Management
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)

Other:
• Usual Care
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)

Locations

Country	Name	City	State
Germany	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
Germany	Oder-Spree-Krankenhaus Beeskow GmbH	Beeskow
Germany	Ärzte Schönhauser Berlin e.V.	Berlin
Germany	Bundeswehr Krankenhaus	Berlin
Germany	Cardio Centrum Berlin GmbH	Berlin
Germany	Charité - Universitaetsmedizin Berlin	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	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	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH	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
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
Germany	Cardiocampus - Kardiologische Gemeinschaftspraxis	Gifhorn
Germany	Praxis Dr. med. Frank Warzok	Gotha
Germany	Praxis Dr. med Karsten Müller	Gräfenhainichen
Germany	Praxis Karsten Müller	Gräfenhainichen
Germany	Universitätsklinikum Halle (Saale)	Halle
Germany	Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH	Hamburg
Germany	Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin	Hannover
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 (Anhalt)
Germany	Asklepios Klinik Langen	Langen
Germany	Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie	Leipzig
Germany	MVZ Lübbenau GmbH	Lübbenau
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
Germany	Praxis Horn	Manschnow
Germany	Praxis Dr. med. Dieter Böhm	Marbach
Germany	Praxis Dr. Jens Taggeselle	Markkleeberg
Germany	Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg	Merseburg
Germany	Kardiologische Praxis Dr. Rheinert	Merzig
Germany	Kardiologie Mühldorf am Inn	Mühldorf Am Inn
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	Kardiologische Gemeinschaftspraxis am Park Sanssouci	Potsdam
Germany	Poliklinik Ernst von Bergmann GmbH	Potsdam
Germany	St. Josefs-Krankenhaus Potsdam-Sanssouci	Potsdam
Germany	Praxis Ehlert	Pritzwalk
Germany	Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto	Riesa
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/Saale
Germany	Thüringen-Kliniken "Georgius Agricola"	Saalfeld/Saale
Germany	Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie	Schneeberg
Germany	Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim	Schopfheim
Germany	Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH	Schwedt/Oder
Germany	Praxis für Kardiologie	Seelow
Germany	Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg	Senftenberg
Germany	Johanniter-Krankenhaus Genthin-Stendal GmbH	Stendal
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

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research, University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Review. — View 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. — View Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm 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. — View Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days.	QoL measured by European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), depression by PHQ-9D and self-care behaviour by European Heart Failure Self-care Behaviour Scale (EHFScBS-9)	12 months (baseline and final visit)
Other	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)
Other	Unplanned cardiovascular hospitalisations and cardiovascular mortality.	Analysed as a recurrent event analysis	individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Other	Unplanned cardiovascular hospitalisations and all-cause mortality.	Analysed as a recurrent event analysis	individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Other	Unplanned heart failure hospitalisations and cardiovascular mortality.	Analysed as a recurrent event analysis	individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Other	Unplanned heart failure hospitalisations and all-cause mortality.	analysed as a recurrent event analysis	12 month
Other	Cost-utility Analysis.	QALY-analysis using EQ-5D-3L	12 month/individual follow-up time
Other	Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation		12 months
Primary	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	All-cause mortality during the individual patient follow-up time.	All-cause and cardiovascular mortality will be calculated as: The individual follow-up time as calculated for the primary outcome + 28 days for all patients to a maximum of 393 days.	individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Secondary	Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.		12 months/ individual follow-up time
Secondary	Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time		12 months/ individual follow-up time
Secondary	Change in MLHFQ-questionnaire overall score between baseline and 365 days	The change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) scores will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided.	12 months/ individual follow-up time
Secondary	Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.	The change in NT-proBNP and of MR-proADM levels will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided	12 months/ individual follow-up time

External Links

•   affiliation website
•   project website, only in German
•   study website, only in German