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AzTrials

Chronic Heart FailurePhase 3TIM-HF2NCT01878630

Telemedical Interventional Management in Heart Failure II

A Phase 3 study testing Remote Patient Management in people with Chronic Heart Failure, run by Charite University, Berlin, Germany at 109 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
Remote Patient Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,571 participants
Where
109 sitesGermany
Study dates
8 Aug 2013to 17 May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

109 sites in 1 country.

109 sites in 1 country

Germany109 sites

  • Klinikum St. Marien Amberg - Medizinische Klinik I

    Amberg

  • GLG Fachklinik Wolletzsee GmbH

    Angermünde

  • Klinik Ernst von Bergmann Bad Belzig gGmbH - Zentrum für Innere Medizin/Kardiologie

    Bad Belzig, 14805

  • Oder-Spree-Krankenhaus Beeskow GmbH

    Beeskow

  • Charité - Universitaetsmedizin Berlin

    Berlin, 10117

  • Bundeswehr Krankenhaus

    Berlin

  • Cardio Centrum Berlin GmbH

    Berlin

  • DRK Kliniken Berlin-Köpenick

    Berlin

  • Gemeinschaftskrankenhaus Havelhöhe Klinik für Anthroposophische Medizin

    Berlin

  • Gemeinschaftspraxis am Bayerischen Platz

    Berlin

  • HELIOS Klinikum Berlin-Buch

    Berlin

  • HELIOS Klinikum Emil von Behring - HELIOS Kliniken GmbH

    Berlin

  • Herzpraxis Berlin

    Berlin

  • Jüdisches Krankenhaus Berlin

    Berlin

  • Kardiologie Weissensee

    Berlin

  • Kardiologische Praxis im Spreebogen

    Berlin

  • Krankenhaus Waldfriede e. V.

    Berlin

  • Kranoldpraxis

    Berlin

  • Martin-Luther Krankenhaus

    Berlin

  • MVZ Treffpunkt Geißenweide GmbH

    Berlin

  • Polikum Institut GmbH Polikum Friede

    Berlin

  • Praxis am Dachsbau

    Berlin

  • Praxis Claus

    Berlin

  • Praxis Dres. Weinrich

    Berlin

  • Praxis Frank

    Berlin

  • Praxis Pinkwart

    Berlin

  • Praxis Roeder

    Berlin

  • Unfallkrankenhaus Berlin

    Berlin

  • Vivantes Klinikum Hellersdorf

    Berlin

  • Vivantes MVZ Wedding

    Berlin

  • Ärzte Schönhauser Berlin e.V.

    Berlin

  • Brandenburgklinik Berlin-Brandenburg GmbH

    Bernau

  • Immanuel Klinikum Bernau, Herzzentrum Brandenburg

    Bernau

  • Kardiologische Praxis Gola

    Bernau

  • Gemeinschaftspraxis Hampel/Janoske

    Bitterfeld-Wolfen

  • Gesundheitszentrum Bitterfeld/Wolfen gGmbH - Zentrum für Innere Medizin/Herzkatheterlabor

    Bitterfeld-Wolfen

  • Städtisches Klinikum Brandenburg/Havel

    Brandenburg/Havel

  • Herz - und Gefäßzentrum am Neumarkt

    Celle

  • Medizinisches Beratungs- und Therapie-Zentrum Chemnitz GmbH

    Chemnitz, 09111

  • Klinikum Chemnitz gGmbH

    Chemnitz

  • Carl-Thiem-Klinikum Cottbus

    Cottbus

  • Klinikum Lippe - Kardiologie

    Detmold

  • Cardiologicum Dresden & Pirna

    Dresden

  • Städtisches Klinikum Dresden-Friedrichstadt

    Dresden

  • Kreisklinik Ebersberg gGmbH

    Ebersberg, 85560

  • Klinikum Barnim GmbH, Werner Forßmann Krankenhaus

    Eberswalde

  • Praxis Hagenow

    Elsterwerda

  • Klinikum der Johann-Wolfgang Goethe-Universität

    Frankfurt am Main

  • Praxis Langel

    Gera

  • Kardiologische Praxis Dr. Wehr

    Gerlingen, 70839

  • Cardiocampus - Kardiologische Gemeinschaftspraxis

    Gifhorn

  • Praxis Dr. med. Frank Warzok

    Gotha, 99867

  • Praxis Karsten Müller

    Gräfenhainichen, 06773

  • Praxis Dr. med Karsten Müller

    Gräfenhainichen

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Albertinen-Krankenhaus/Albertinen-Haus gemeinnützige GmbH

    Hamburg

  • Medizinische Hochschule Hannover -Klinik für Kardiologie und Angiologie/ Zentrum Innere Medizin

    Hanover

  • Universitätsklinikum Jena

    Jena

  • Kardiologie im Praxishaus

    Kleinmachnow

  • Klinikum Dahme-Spreewald GmbH/Achenbach-Krankenhaus

    Königs Wusterhausen

  • HELIOS Klinik Köthen - Klinik für Innere Medizin, Schwerpunkt Kardiologie, Internistische Intensivmedizin

    Köthen

  • Asklepios Klinik Langen

    Langen

  • Universitätsklinikum Leipzig - Abteilung Kardiologie & Angiologie

    Leipzig

  • MVZ Lübbenau GmbH

    Lubnjow

  • Cardio Centrum Ludwigsburg Bietigheim

    Ludwigsburg

  • Kardiologische Gemeinschaftspraxis Dr. med. Bartels, Dr. med. Kausche, Dr. med. Meltendorf

    Magdeburg

  • Dietrich Bonhoeffer Klinikum - Klinik für Innere Medizin 4

    Malchin, 17139

  • Praxis Horn

    Manschnow

  • Praxis Dr. med. Dieter Böhm

    Marbach, 71672

  • Praxis Dr. Jens Taggeselle

    Markkleeberg, 04416

  • Carl-von-Basedow-Klinikum Saalekreis gGmbH, Klinikum Merseburg

    Merseburg

  • Kardiologische Praxis Dr. Rheinert

    Merzig, 66663

  • Kardiologie Mühldorf am Inn

    Mühldorf

  • Kardiologische Praxis Nauen

    Nauen

  • Dietrich Bonhoeffer Klinikum

    Neubrandenburg

  • Ruppiner Kliniken GmbH

    Neuruppin

  • Kardiologische Praxis Dr. H.P. Mieg

    Oranienburg

  • Praxis Donaubauer

    Oschatz

  • Internist; Facharzt für Innere Medizin

    Pasewalk

  • Kreiskrankenhaus Prignitz gGmbH

    Perleberg

  • Cardiologicum

    Pirna

  • St. Josefs-Krankenhaus Potsdam-Sanssouci

    Potsdam, 14471

  • Kardiologische Gemeinschaftspraxis am Park Sanssouci

    Potsdam

  • Poliklinik Ernst von Bergmann GmbH

    Potsdam

  • Praxis Ehlert

    Pritzwalk

  • Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto

    Riesa, 01587

  • Gemeinschaftspraxis Dres. Stenzel/Ebert/Otto

    Riesa

  • Kardiologische Praxis Dr. Placke

    Rostock

  • Facharzt-Zentrum Pneumologie und Kardiologie

    Rüdersdorf

  • Klinik am See/REHA-Fachklinik für Innere Medizin

    Rüdersdorf

  • Praxis für Kardiologie

    Saalfeld

  • Thüringen-Kliniken "Georgius Agricola"

    Saalfeld

  • Bergarbeiter-Krankenhaus Schneeberg GmbH - Innere Medizin/Kardiologie

    Schneeberg

  • Kliniken des Landkreises Lörrach GmbH, KKH Schopfheim

    Schopfheim, 79650

  • Asklepios Klinikum Uckermark GmbH - Asklepios Kliniken GmbH

    Schwedt

  • Praxis für Kardiologie

    Seelow

  • Praxisklinik Herz und Gefäße - ZWEIGPRAXIS Brandenburg

    Senftenberg

  • Johanniter-Krankenhaus Genthin-Stendal GmbH

    Stendal, 39576

  • Internistische Gemeinschaftspraxis Steiner Thor

    Straubing

  • Klinikum St. Elisabeth Straubing GmbH

    Straubing

  • Internistische Praxis am Landsberger Tor

    Strausberg

  • Kardiologische Facharztpraxis Dr. med. Heike Olthoff

    Strausberg

  • Robert Bosch Krankenhaus Stuttgart

    Stuttgart

  • Sana-Kliniken Berlin-Brandenburg GmbH

    Templin

  • Kardiologische Gemeinschaftspraxis Wittenberg

    Wittenberg

  • Praxis Stiller

    Wittstock

  • Ambulantes Herz-Kreislauf Zentrum Wolfsburg

    Wolfsburg

  • Universitätsklinikum Würzburg

    Würzburg

  • Praxis Lägel

    Zeuthen

Other trials in Germany

About this study

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
Read the 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.

Being tested
Remote Patient Management, Usual Care
Keywords
Chronic Heart Failure, CHF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Patient ManagementDevice

    Also called R&D project "Fontane"

    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)

  • Usual CareOther

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

Study groups in NCT01878630
Study groupRoleWhat they receive
Remote Patient ManagementExperimentalintervention group
Receives: Device: Remote Patient Management
Usual CareActive comparatorcontrol group
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months/ individual-patient follow-up time.

Secondary outcomes (5)

  1. 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.

    Measured: individual patient follow-up time (+28 days of the final visit to a maximum 393 days)

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

    Measured: 12 months/ individual follow-up time

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

    Measured: 12 months/ individual follow-up time

  4. 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.

    Measured: 12 months/ individual follow-up time

  5. 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

    Measured: 12 months/ individual follow-up time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2013 (estimated)
  2. Study start8 Aug 2013
  3. Primary completion12 May 2017
  4. Study completion17 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking
None (open label)
Enrolment
1,571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01878630
Sponsor's protocol ID
13KQ0904B
Acronym
TIM-HF2
Status last verified
Aug 2018
First submitted
12 Jun 2013
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21982700

  • 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.

    PubMed 21444883

  • 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.

    PubMed 21856487

  • 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.

    PubMed 26303835

  • Kerwagen 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.

    PubMed 40672055

  • Koehler 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.

    PubMed 38867198

  • Kerwagen 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.

    PubMed 37368507

  • Deckwart 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.

    PubMed 36752782

  • 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.

    PubMed 36062451

  • 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.

    PubMed 33328035

  • 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.

    PubMed 30230666

  • 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.

    PubMed 30153985

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remote Patient Management in people with Chronic Heart Failure, run by Charite University, Berlin, Germany at 109 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 months/ individual-patient follow-up time.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01878630, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

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