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

Primary Purpose

Chronic Heart Failure

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Remote Patient Management
Usual Care
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, CHF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Klinikum St. Marien Amberg - Medizinische Klinik I
  • GLG Fachklinik Wolletzsee GmbH
  • Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie
  • Oder-Spree-Krankenhaus Beeskow GmbH
  • Charité - Universitaetsmedizin Berlin
  • Bundeswehr Krankenhaus
  • Cardio Centrum Berlin GmbH
  • DRK Kliniken Berlin-Köpenick
  • Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin
  • Gemeinschaftspraxis am Bayerischen Platz
  • HELIOS Klinikum Berlin-Buch
  • HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH
  • Herzpraxis Berlin
  • Jüdisches Krankenhaus Berlin
  • Kardiologie Weissensee
  • Kardiologische Praxis im Spreebogen
  • Krankenhaus Waldfriede e. V.
  • Kranoldpraxis
  • Martin-Luther Krankenhaus
  • MVZ Treffpunkt Geißenweide GmbH
  • Polikum Institut GmbH Polikum Friede
  • Praxis am Dachsbau
  • Praxis Claus
  • Praxis Dres. Weinrich
  • Praxis Frank
  • Praxis Pinkwart
  • Praxis Roeder
  • Unfallkrankenhaus Berlin
  • Vivantes Klinikum Hellersdorf
  • Vivantes MVZ Wedding
  • Ärzte Schönhauser Berlin e.V.
  • Brandenburgklinik Berlin-Brandenburg GmbH
  • Immanuel Klinikum Bernau, Herzzentrum Brandenburg
  • Kardiologische Praxis Gola
  • Gemeinschaftspraxis Hampel/Janoske
  • Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor
  • Städtisches Klinikum Brandenburg/Havel
  • Herz - und Gefäßzentrum am Neumarkt
  • Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH
  • Klinikum Chemnitz gGmbH
  • Carl-Thiem-Klinikum Cottbus
  • Klinikum Lippe - Kardiologie
  • Cardiologicum Dresden & Pirna
  • Städtisches Klinikum Dresden-Friedrichstadt
  • Kreisklinik Ebersberg gGmbH
  • Klinikum Barnim GmbH, Werner Forßmann Krankenhaus
  • Praxis Hagenow
  • Klinikum der Johann-Wolfgang Goethe-Universität
  • Praxis Langel
  • Kardiologische Praxis Dr. Wehr
  • Cardiocampus - Kardiologische Gemeinschaftspraxis
  • Praxis Dr. med. Frank Warzok
  • Praxis Karsten Müller
  • Praxis Dr. med Karsten Müller
  • Universitätsklinikum Halle (Saale)
  • Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH
  • Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin
  • Universitätsklinikum Jena
  • Kardiologie im Praxishaus
  • Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus
  • HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin
  • Asklepios Klinik Langen
  • Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie
  • Cardio Centrum Ludwigsburg Bietigheim
  • MVZ Lübbenau GmbH
  • Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf
  • Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4
  • Praxis Horn
  • Praxis Dr. med. Dieter Böhm
  • Praxis Dr. Jens Taggeselle
  • Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg
  • Kardiologische Praxis Dr. Rheinert
  • Kardiologie Mühldorf am Inn
  • Kardiologische Praxis Nauen
  • Dietrich Bonhoeffer Klinikum
  • Ruppiner Kliniken GmbH
  • Kardiologische Praxis Dr. H.P. Mieg
  • Praxis Donaubauer
  • Internist; Facharzt für Innere Medizin
  • Kreiskrankenhaus Prignitz gGmbH
  • Cardiologicum
  • St. Josefs-Krankenhaus Potsdam-Sanssouci
  • Kardiologische Gemeinschaftspraxis am Park Sanssouci
  • Poliklinik Ernst von Bergmann GmbH
  • Praxis Ehlert
  • Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
  • Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
  • Kardiologische Praxis Dr. Placke
  • Facharzt-Zentrum Pneumologie und Kardiologie
  • Klinik am See/REHA-Fachklinik für Innere Medizin
  • Praxis für Kardiologie
  • Thüringen-Kliniken "Georgius Agricola"
  • Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie
  • Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim
  • Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH
  • Praxis für Kardiologie
  • Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg
  • Johanniter-Krankenhaus Genthin-Stendal GmbH
  • Internistische Gemeinschaftspraxis Steiner Thor
  • Klinikum St. Elisabeth Straubing GmbH
  • Internistische Praxis am Landsberger Tor
  • Kardiologische Facharztpraxis Dr. med. Heike Olthoff
  • Robert Bosch Krankenhaus Stuttgart
  • Sana-Kliniken Berlin-Brandenburg GmbH
  • Kardiologische Gemeinschaftspraxis Wittenberg
  • Praxis Stiller
  • Ambulantes Herz-Kreislauf Zentrum Wolfsburg
  • Universitätsklinikum Würzburg
  • Praxis Lägel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote Patient Management

Usual Care

Arm Description

intervention group

control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time
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.
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

Full Information

First Posted
June 12, 2013
Last Updated
August 2, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research, University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT01878630
Brief Title
Telemedical Interventional Management in Heart Failure II
Acronym
TIM-HF2
Official Title
Telemedical Interventional Management in Heart Failure II
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 8, 2013 (undefined)
Primary Completion Date
May 12, 2017 (Actual)
Study Completion Date
May 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research, University of Leipzig

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, CHF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1571 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Patient Management
Arm Type
Experimental
Arm Description
intervention group
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
Remote Patient Management
Other Intervention Name(s)
R&D project "Fontane"
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
Primary Outcome Measure Information:
Title
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
Description
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.
Time Frame
12 months/ individual-patient follow-up time.
Secondary Outcome Measure Information:
Title
All-cause mortality during the individual patient follow-up time.
Description
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.
Time Frame
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Title
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
Time Frame
12 months/ individual follow-up time
Title
Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time
Time Frame
12 months/ individual follow-up time
Title
Change in MLHFQ-questionnaire overall score between baseline and 365 days
Description
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.
Time Frame
12 months/ individual follow-up time
Title
Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.
Description
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
Time Frame
12 months/ individual follow-up time
Other Pre-specified Outcome Measures:
Title
Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days.
Description
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)
Time Frame
12 months (baseline and final visit)
Title
Change from baseline in biomarkers (MR-proADM, NT-proBNP, MR-proANP, PCT) stratified by LVEF (>45 vs ≤ 45) at 365 days.
Time Frame
12 months (baseline and final visit)
Title
Unplanned cardiovascular hospitalisations and cardiovascular mortality.
Description
Analysed as a recurrent event analysis
Time Frame
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Title
Unplanned cardiovascular hospitalisations and all-cause mortality.
Description
Analysed as a recurrent event analysis
Time Frame
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Title
Unplanned heart failure hospitalisations and cardiovascular mortality.
Description
Analysed as a recurrent event analysis
Time Frame
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Title
Unplanned heart failure hospitalisations and all-cause mortality.
Description
analysed as a recurrent event analysis
Time Frame
12 month
Title
Cost-utility Analysis.
Description
QALY-analysis using EQ-5D-3L
Time Frame
12 month/individual follow-up time
Title
Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedrich Koehler, Prof. Dr.
Organizational Affiliation
Charité - Universitaetsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum St. Marien Amberg - Medizinische Klinik I
City
Amberg
Country
Germany
Facility Name
GLG Fachklinik Wolletzsee GmbH
City
Angermünde
Country
Germany
Facility Name
Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie
City
Bad Belzig
ZIP/Postal Code
14805
Country
Germany
Facility Name
Oder-Spree-Krankenhaus Beeskow GmbH
City
Beeskow
Country
Germany
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Bundeswehr Krankenhaus
City
Berlin
Country
Germany
Facility Name
Cardio Centrum Berlin GmbH
City
Berlin
Country
Germany
Facility Name
DRK Kliniken Berlin-Köpenick
City
Berlin
Country
Germany
Facility Name
Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin
City
Berlin
Country
Germany
Facility Name
Gemeinschaftspraxis am Bayerischen Platz
City
Berlin
Country
Germany
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
Country
Germany
Facility Name
HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH
City
Berlin
Country
Germany
Facility Name
Herzpraxis Berlin
City
Berlin
Country
Germany
Facility Name
Jüdisches Krankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Kardiologie Weissensee
City
Berlin
Country
Germany
Facility Name
Kardiologische Praxis im Spreebogen
City
Berlin
Country
Germany
Facility Name
Krankenhaus Waldfriede e. V.
City
Berlin
Country
Germany
Facility Name
Kranoldpraxis
City
Berlin
Country
Germany
Facility Name
Martin-Luther Krankenhaus
City
Berlin
Country
Germany
Facility Name
MVZ Treffpunkt Geißenweide GmbH
City
Berlin
Country
Germany
Facility Name
Polikum Institut GmbH Polikum Friede
City
Berlin
Country
Germany
Facility Name
Praxis am Dachsbau
City
Berlin
Country
Germany
Facility Name
Praxis Claus
City
Berlin
Country
Germany
Facility Name
Praxis Dres. Weinrich
City
Berlin
Country
Germany
Facility Name
Praxis Frank
City
Berlin
Country
Germany
Facility Name
Praxis Pinkwart
City
Berlin
Country
Germany
Facility Name
Praxis Roeder
City
Berlin
Country
Germany
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Hellersdorf
City
Berlin
Country
Germany
Facility Name
Vivantes MVZ Wedding
City
Berlin
Country
Germany
Facility Name
Ärzte Schönhauser Berlin e.V.
City
Berlin
Country
Germany
Facility Name
Brandenburgklinik Berlin-Brandenburg GmbH
City
Bernau
Country
Germany
Facility Name
Immanuel Klinikum Bernau, Herzzentrum Brandenburg
City
Bernau
Country
Germany
Facility Name
Kardiologische Praxis Gola
City
Bernau
Country
Germany
Facility Name
Gemeinschaftspraxis Hampel/Janoske
City
Bitterfeld-Wolfen
Country
Germany
Facility Name
Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor
City
Bitterfeld-Wolfen
Country
Germany
Facility Name
Städtisches Klinikum Brandenburg/Havel
City
Brandenburg/Havel
Country
Germany
Facility Name
Herz - und Gefäßzentrum am Neumarkt
City
Celle
Country
Germany
Facility Name
Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH
City
Chemnitz
ZIP/Postal Code
09111
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
Country
Germany
Facility Name
Carl-Thiem-Klinikum Cottbus
City
Cottbus
Country
Germany
Facility Name
Klinikum Lippe - Kardiologie
City
Detmold
Country
Germany
Facility Name
Cardiologicum Dresden & Pirna
City
Dresden
Country
Germany
Facility Name
Städtisches Klinikum Dresden-Friedrichstadt
City
Dresden
Country
Germany
Facility Name
Kreisklinik Ebersberg gGmbH
City
Ebersberg
ZIP/Postal Code
85560
Country
Germany
Facility Name
Klinikum Barnim GmbH, Werner Forßmann Krankenhaus
City
Eberswalde
Country
Germany
Facility Name
Praxis Hagenow
City
Elsterwerda
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang Goethe-Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Praxis Langel
City
Gera
Country
Germany
Facility Name
Kardiologische Praxis Dr. Wehr
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Cardiocampus - Kardiologische Gemeinschaftspraxis
City
Gifhorn
Country
Germany
Facility Name
Praxis Dr. med. Frank Warzok
City
Gotha
ZIP/Postal Code
99867
Country
Germany
Facility Name
Praxis Karsten Müller
City
Gräfenhainichen
ZIP/Postal Code
06773
Country
Germany
Facility Name
Praxis Dr. med Karsten Müller
City
Gräfenhainichen
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin
City
Hannover
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Facility Name
Kardiologie im Praxishaus
City
Kleinmachnow
Country
Germany
Facility Name
Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus
City
Königs-Wusterhausen
Country
Germany
Facility Name
HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin
City
Köthen (Anhalt)
Country
Germany
Facility Name
Asklepios Klinik Langen
City
Langen
Country
Germany
Facility Name
Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie
City
Leipzig
Country
Germany
Facility Name
Cardio Centrum Ludwigsburg Bietigheim
City
Ludwigsburg
Country
Germany
Facility Name
MVZ Lübbenau GmbH
City
Lübbenau
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf
City
Magdeburg
Country
Germany
Facility Name
Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4
City
Malchin
ZIP/Postal Code
17139
Country
Germany
Facility Name
Praxis Horn
City
Manschnow
Country
Germany
Facility Name
Praxis Dr. med. Dieter Böhm
City
Marbach
ZIP/Postal Code
71672
Country
Germany
Facility Name
Praxis Dr. Jens Taggeselle
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg
City
Merseburg
Country
Germany
Facility Name
Kardiologische Praxis Dr. Rheinert
City
Merzig
ZIP/Postal Code
66663
Country
Germany
Facility Name
Kardiologie Mühldorf am Inn
City
Mühldorf Am Inn
Country
Germany
Facility Name
Kardiologische Praxis Nauen
City
Nauen
Country
Germany
Facility Name
Dietrich Bonhoeffer Klinikum
City
Neubrandenburg
Country
Germany
Facility Name
Ruppiner Kliniken GmbH
City
Neuruppin
Country
Germany
Facility Name
Kardiologische Praxis Dr. H.P. Mieg
City
Oranienburg
Country
Germany
Facility Name
Praxis Donaubauer
City
Oschatz
Country
Germany
Facility Name
Internist; Facharzt für Innere Medizin
City
Pasewalk
Country
Germany
Facility Name
Kreiskrankenhaus Prignitz gGmbH
City
Perleberg
Country
Germany
Facility Name
Cardiologicum
City
Pirna
Country
Germany
Facility Name
St. Josefs-Krankenhaus Potsdam-Sanssouci
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis am Park Sanssouci
City
Potsdam
Country
Germany
Facility Name
Poliklinik Ernst von Bergmann GmbH
City
Potsdam
Country
Germany
Facility Name
Praxis Ehlert
City
Pritzwalk
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
City
Riesa
ZIP/Postal Code
01587
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
City
Riesa
Country
Germany
Facility Name
Kardiologische Praxis Dr. Placke
City
Rostock
Country
Germany
Facility Name
Facharzt-Zentrum Pneumologie und Kardiologie
City
Rüdersdorf
Country
Germany
Facility Name
Klinik am See/REHA-Fachklinik für Innere Medizin
City
Rüdersdorf
Country
Germany
Facility Name
Praxis für Kardiologie
City
Saalfeld/Saale
Country
Germany
Facility Name
Thüringen-Kliniken "Georgius Agricola"
City
Saalfeld/Saale
Country
Germany
Facility Name
Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie
City
Schneeberg
Country
Germany
Facility Name
Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim
City
Schopfheim
ZIP/Postal Code
79650
Country
Germany
Facility Name
Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH
City
Schwedt/Oder
Country
Germany
Facility Name
Praxis für Kardiologie
City
Seelow
Country
Germany
Facility Name
Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg
City
Senftenberg
Country
Germany
Facility Name
Johanniter-Krankenhaus Genthin-Stendal GmbH
City
Stendal
ZIP/Postal Code
39576
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis Steiner Thor
City
Straubing
Country
Germany
Facility Name
Klinikum St. Elisabeth Straubing GmbH
City
Straubing
Country
Germany
Facility Name
Internistische Praxis am Landsberger Tor
City
Strausberg
Country
Germany
Facility Name
Kardiologische Facharztpraxis Dr. med. Heike Olthoff
City
Strausberg
Country
Germany
Facility Name
Robert Bosch Krankenhaus Stuttgart
City
Stuttgart
Country
Germany
Facility Name
Sana-Kliniken Berlin-Brandenburg GmbH
City
Templin
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis Wittenberg
City
Wittenberg
Country
Germany
Facility Name
Praxis Stiller
City
Wittstock
Country
Germany
Facility Name
Ambulantes Herz-Kreislauf Zentrum Wolfsburg
City
Wolfsburg
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
Praxis Lägel
City
Zeuthen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21982700
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.
Results Reference
background
PubMed Identifier
21444883
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.
Results Reference
background
PubMed Identifier
21856487
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.
Results Reference
background
PubMed Identifier
26303835
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.
Results Reference
background
PubMed Identifier
36062451
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.
Results Reference
derived
PubMed Identifier
33328035
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.
Results Reference
derived
PubMed Identifier
30230666
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.
Results Reference
derived
PubMed Identifier
30153985
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.
Results Reference
derived
Links:
URL
http://telemedizin.charite.de/en/
Description
affiliation website
URL
http://www.gesundheitsregion-fontane.de
Description
project website, only in German

Learn more about this trial

Telemedical Interventional Management in Heart Failure II

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