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

August 2, 2018 updated by: Friedrich Koehler, Charite University, Berlin, Germany

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1571

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany
        • Klinikum St. Marien Amberg - Medizinische Klinik I
      • Angermünde, Germany
        • GLG Fachklinik Wolletzsee GmbH
      • Bad Belzig, Germany, 14805
        • Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie
      • Beeskow, Germany
        • Oder-Spree-Krankenhaus Beeskow GmbH
      • Berlin, Germany, 10117
        • Charite - Universitaetsmedizin Berlin
      • Berlin, Germany
        • Jüdisches Krankenhaus Berlin
      • Berlin, Germany
        • Helios Klinikum Berlin-Buch
      • Berlin, Germany
        • Unfallkrankenhaus Berlin
      • Berlin, 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 Emil von Behring - HELIOS Kliniken GmbH
      • Berlin, Germany
        • Herzpraxis 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
        • Vivantes Klinikum Hellersdorf
      • Berlin, Germany
        • Vivantes MVZ Wedding
      • Berlin, Germany
        • Ärzte Schönhauser Berlin e.V.
      • Bernau, Germany
        • Brandenburgklinik Berlin-Brandenburg GmbH
      • Bernau, Germany
        • Immanuel Klinikum Bernau, Herzzentrum Brandenburg
      • Bernau, Germany
        • Kardiologische Praxis Gola
      • Bitterfeld-Wolfen, Germany
        • Gemeinschaftspraxis Hampel/Janoske
      • Bitterfeld-Wolfen, Germany
        • Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor
      • Brandenburg/Havel, Germany
        • Städtisches Klinikum Brandenburg/Havel
      • Celle, Germany
        • Herz - und Gefäßzentrum am Neumarkt
      • Chemnitz, Germany
        • Klinikum Chemnitz gGmbH
      • Chemnitz, Germany, 09111
        • Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH
      • Cottbus, Germany
        • Carl-Thiem-Klinikum Cottbus
      • Detmold, Germany
        • Klinikum Lippe - Kardiologie
      • Dresden, Germany
        • Städtisches Klinikum Dresden-Friedrichstadt
      • Dresden, Germany
        • Cardiologicum Dresden & Pirna
      • Ebersberg, Germany, 85560
        • Kreisklinik Ebersberg gGmbH
      • Eberswalde, Germany
        • Klinikum Barnim GmbH, Werner Forssmann Krankenhaus
      • Elsterwerda, Germany
        • Praxis Hagenow
      • Frankfurt am Main, Germany
        • Klinikum der Johann-Wolfgang Goethe-Universitat
      • Gera, Germany
        • Praxis Langel
      • Gerlingen, Germany, 70839
        • Kardiologische Praxis Dr. Wehr
      • Gifhorn, Germany
        • Cardiocampus - Kardiologische Gemeinschaftspraxis
      • Gotha, Germany, 99867
        • Praxis Dr. med. Frank Warzok
      • Gräfenhainichen, Germany, 06773
        • Praxis Karsten Müller
      • Gräfenhainichen, Germany
        • Praxis Dr. med Karsten Müller
      • Halle, Germany, 06120
        • Universitätsklinikum Halle (Saale)
      • Hamburg, Germany
        • Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH
      • Hannover, Germany
        • Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin
      • Jena, Germany
        • Universitatsklinikum Jena
      • Kleinmachnow, Germany
        • Kardiologie im Praxishaus
      • Königs-Wusterhausen, Germany
        • Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus
      • Köthen (Anhalt), Germany
        • HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin
      • Langen, Germany
        • Asklepios Klinik Langen
      • Leipzig, Germany
        • Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie
      • Ludwigsburg, Germany
        • Cardio Centrum Ludwigsburg Bietigheim
      • Lübbenau, Germany
        • MVZ Lübbenau GmbH
      • Magdeburg, Germany
        • Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf
      • Malchin, Germany, 17139
        • Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4
      • Manschnow, Germany
        • Praxis Horn
      • Marbach, Germany, 71672
        • Praxis Dr. med. Dieter Böhm
      • Markkleeberg, Germany, 04416
        • Praxis Dr. Jens Taggeselle
      • Merseburg, Germany
        • Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg
      • Merzig, Germany, 66663
        • Kardiologische Praxis Dr. Rheinert
      • Mühldorf Am Inn, Germany
        • Kardiologie Mühldorf am Inn
      • Nauen, Germany
        • Kardiologische Praxis Nauen
      • Neubrandenburg, Germany
        • Dietrich Bonhoeffer Klinikum
      • Neuruppin, Germany
        • Ruppiner Kliniken GmbH
      • Oranienburg, Germany
        • Kardiologische Praxis Dr. H.P. Mieg
      • Oschatz, Germany
        • Praxis Donaubauer
      • Pasewalk, Germany
        • Internist; Facharzt für Innere Medizin
      • Perleberg, Germany
        • Kreiskrankenhaus Prignitz gGmbH
      • Pirna, Germany
        • Cardiologicum
      • Potsdam, Germany, 14471
        • St. Josefs-Krankenhaus Potsdam-Sanssouci
      • Potsdam, Germany
        • Kardiologische Gemeinschaftspraxis am Park Sanssouci
      • Potsdam, Germany
        • Poliklinik Ernst von Bergmann GmbH
      • Pritzwalk, Germany
        • Praxis Ehlert
      • Riesa, Germany, 01587
        • Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
      • Riesa, Germany
        • Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto
      • Rostock, Germany
        • Kardiologische Praxis Dr. Placke
      • Rüdersdorf, Germany
        • Facharzt-Zentrum Pneumologie und Kardiologie
      • Rüdersdorf, Germany
        • Klinik am See/REHA-Fachklinik für Innere Medizin
      • Saalfeld/Saale, Germany
        • Praxis für Kardiologie
      • Saalfeld/Saale, Germany
        • Thüringen-Kliniken "Georgius Agricola"
      • Schneeberg, Germany
        • Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie
      • Schopfheim, Germany, 79650
        • Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim
      • Schwedt/Oder, Germany
        • Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH
      • Seelow, Germany
        • Praxis für Kardiologie
      • Senftenberg, Germany
        • Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg
      • Stendal, Germany, 39576
        • Johanniter-Krankenhaus Genthin-Stendal GmbH
      • Straubing, Germany
        • Internistische Gemeinschaftspraxis Steiner Thor
      • Straubing, Germany
        • Klinikum St. Elisabeth Straubing GmbH
      • Strausberg, Germany
        • Internistische Praxis am Landsberger Tor
      • Strausberg, Germany
        • Kardiologische Facharztpraxis Dr. med. Heike Olthoff
      • Stuttgart, Germany
        • Robert Bosch Krankenhaus Stuttgart
      • Templin, Germany
        • Sana-Kliniken Berlin-Brandenburg GmbH
      • Wittenberg, Germany
        • Kardiologische Gemeinschaftspraxis Wittenberg
      • Wittstock, Germany
        • Praxis Stiller
      • Wolfsburg, Germany
        • Ambulantes Herz-Kreislauf Zentrum Wolfsburg
      • Würzburg, Germany
        • Universitatsklinikum Wurzburg
      • Zeuthen, Germany
        • Praxis Lägel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Remote Patient Management
intervention group
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 Names:
  • R&D project "Fontane"
ACTIVE_COMPARATOR: Usual Care
control group
Other: Usual Care
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
Time Frame: 12 months/ 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality during the individual patient follow-up time.
Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
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)
Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.
Time Frame: 12 months/ individual 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
Time Frame: 12 months/ individual follow-up time
12 months/ individual follow-up time
Change in MLHFQ-questionnaire overall score between baseline and 365 days
Time Frame: 12 months/ individual follow-up time
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
Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.
Time Frame: 12 months/ individual follow-up time
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days.
Time Frame: 12 months (baseline and final visit)
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)
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)
12 months (baseline and final visit)
Unplanned cardiovascular hospitalisations and cardiovascular mortality.
Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Analysed as a recurrent event analysis
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Unplanned cardiovascular hospitalisations and all-cause mortality.
Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Analysed as a recurrent event analysis
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Unplanned heart failure hospitalisations and cardiovascular mortality.
Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Analysed as a recurrent event analysis
individual patient follow-up time (+28 days of the final visit to a maximum 393 days)
Unplanned heart failure hospitalisations and all-cause mortality.
Time Frame: 12 month
analysed as a recurrent event analysis
12 month
Cost-utility Analysis.
Time Frame: 12 month/individual follow-up time
QALY-analysis using EQ-5D-3L
12 month/individual follow-up time
Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research
University of Leipzig

Investigators

  • Principal Investigator: Friedrich Koehler, Prof. Dr., Charite - Universitaetsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 8, 2013

Primary Completion (ACTUAL)

May 12, 2017

Study Completion (ACTUAL)

May 17, 2018

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (ESTIMATE)

June 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13KQ0904B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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