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Chronic Heart FailurePhase 3TIM-HFNCT00543881

Telemedical Interventional Monitoring in Heart Failure

A Phase 3 study testing Remote patient monitoring (Partnership for the Heart) in people with Chronic Heart Failure, run by Charite University, Berlin, Germany at 2 sites in Germany.

Completed

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

Official record
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Trial summary

Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of: reduction of mortality rate reduction of hospitalizations increasement of patients' 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 monitoring (Partnership for the Heart)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
710 participants
Where
2 sitesGermany
Study dates
Jan 2008to Oct 2010
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

  • Ambulatory CHF NYHA II or III
  • LVEF ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or LVEF ≤ 25%, measured twice within past 6 months
  • Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
  • Age ≥ 18 years
  • Informed consent

Who cannot join

  • Existence of any disease (HF excluded) reducing life expectancy to less than 1 year
  • Insufficient compliance to telemonitoring or study visits
  • Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)
  • Pregnancy
  • Concurrent participation in other therapy trials
  • Hospitalization for cardiac decompensation within 7 days before inclusion in trial
Show all 18Show fewer
  • Implanted cardiac assist system
  • Unstable angina pectoris
  • Congenital heart defect
  • Primary heart valve disease
  • Hypertrophic or restrictive cardiomyopathy
  • Arrhythmogenic right ventricular cardiomyopathy
  • Acute myocarditis diagnosis ,1 year
  • Actively listed for heart transplantation
  • Planned revascularization or CRT implantation
  • Chronic renal insufficiency with creatinine .2.5 mg/dl
  • Liver cirrhosis
  • Known alcohol or drug abuse

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité - Universitaetsmedizin Berlin

    Berlin, 10117

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

Other trials in Germany

About this study

Official title: Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of:

  • reduction of mortality rate
  • reduction of hospitalizations
  • increasement of patients' quality of life
Read the detailed description

The clinical trial assesses 710 patients over a period of at least 15 months each (2008 until 2010); all participants will continue to receive usual care from their GP. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 355 of the patients will be randomly allocated to receive devices for Remote Patient Monitoring 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 monitoring (Partnership for the Heart), Usual care group
Keywords
telemedicine, remote patient monitoring, chronic heart failure, mortality, health economics

What participants receive

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

  • Remote patient monitoring (Partnership for the Heart)Device

    Also called brand name for remote patient monitoring system: Partnership for the Heart

    Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits plus daily monitoring of ECG, weight, blood pressure, self-report of health status, weekly monitoring of physical fitness

  • Usual care groupDevice

    Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits

Study groups in NCT00543881
Study groupRoleWhat they receive
1ExperimentalInterventional group
Receives: Device: Remote patient monitoring (Partnership for the Heart)
2Active comparatorUsual care group
Receives: Device: Usual care group

What is being measured

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

  1. all cause mortality

Secondary outcomes (1)

  1. comp of the combined rate of cv death and hosp. for worsening HF;days lost due to cv death or HF hosp;cv mortality;Rate of cv hosp;Rate of hosp for HF;hosp for any reason;cv hosp;hosp for HF;duration of all hosp for HF;NYHA class; SF-36; PHQ-9 score

Timeline

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

  1. First posted15 Oct 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionJul 2010
  4. Study completionOct 2010

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
Masking
None (open label)
Enrolment
710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00543881
Sponsor's protocol ID
01MG531
Acronym
TIM-HF
Status last verified
Dec 2016
First submitted
11 Oct 2007
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Koehler F, Anker SD. Noninvasive home telemonitoring: the Trans-European Network-Home-Care Management System. J Am Coll Cardiol. 2006 Aug 15;48(4):850-1; author reply 851-2. doi: 10.1016/j.jacc.2006.05.033. Epub 2006 Jul 24. No abstract available.

    PubMed 16904569

  • Kohler F, Schieber M, Lucke S, Heinze P, Henke S, Matthesius G, Pferdt T, Wegertseder D, Stoll M, Anker SD. ["Partnership for the Heart"--development and testing of a new remote patient monitoring system]. Dtsch Med Wochenschr. 2007 Mar 2;132(9):458-60. doi: 10.1055/s-2007-970358. No abstract available. German.

    PubMed 17315125

  • Winkler S, Schieber M, Lucke S, Heinze P, Schweizer T, Wegertseder D, Scherf M, Nettlau H, Henke S, Braecklein M, Anker SD, Koehler F. A new telemonitoring system intended for chronic heart failure patients using mobile telephone technology--feasibility study. Int J Cardiol. 2011 Nov 17;153(1):55-8. doi: 10.1016/j.ijcard.2010.08.038. Epub 2010 Sep 18.

    PubMed 20851481

  • 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

  • Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Kim SS, Koehler K, Lucke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan BA, Gelbrich G, Anker SD; TIM-HF Investigators. Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail. 2010 Dec;12(12):1354-62. doi: 10.1093/eurjhf/hfq199.

    PubMed 21098580

  • 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

  • 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

  • Prescher S, Deckwart O, Winkler S, Koehler K, Honold M, Koehler F. Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial. Eur J Prev Cardiol. 2013 Jun;20(2 Suppl):18-24. doi: 10.1177/2047487313487483e.

    PubMed 23702987

  • Jehn M, Prescher S, Koehler K, von Haehling S, Winkler S, Deckwart O, Honold M, Sechtem U, Baumann G, Halle M, Anker SD, Koehler F. Tele-accelerometry as a novel technique for assessing functional status in patients with heart failure: feasibility, reliability and patient safety. Int J Cardiol. 2013 Oct 12;168(5):4723-8. doi: 10.1016/j.ijcard.2013.07.171. Epub 2013 Jul 25.

    PubMed 23962782

  • Prescher S, Deckwart O, Koehler K, Lucke S, Schieber M, Wellge B, Winkler S, Baumann G, Koehler F. [Will telemonitoring be adopted by patients with chronic heart failure?]. Dtsch Med Wochenschr. 2014 Apr;139(16):829-34. doi: 10.1055/s-0034-1369849. Epub 2014 Apr 10. German.

    PubMed 24722932

  • Prescher S, Schoebel C, Koehler K, Deckwart O, Wellge B, Honold M, Hartmann O, Winkler S, Koehler F. Prognostic value of serial six-minute walk tests using tele-accelerometry in patients with chronic heart failure: A pre-specified sub-study of the TIM-HF-Trial. Eur J Prev Cardiol. 2016 Oct;23(2 suppl):21-26. doi: 10.1177/2047487316671438.

    PubMed 27892422

  • Jehn M, Halle M, Schuster T, Hanssen H, Koehler F, Schmidt-Trucksass A. Multivariable analysis of heart rate recovery after cycle ergometry in heart failure: exercise in heart failure. Heart Lung. 2011 Nov-Dec;40(6):e129-37. doi: 10.1016/j.hrtlng.2011.01.005. Epub 2011 Mar 23.

    PubMed 21429580

  • Jehn M, Halle M, Schuster T, Hanssen H, Weis M, Koehler F, Schmidt-Trucksass A. The 6-min walk test in heart failure: is it a max or sub-maximum exercise test? Eur J Appl Physiol. 2009 Oct;107(3):317-23. doi: 10.1007/s00421-009-1128-0. Epub 2009 Jul 18.

    PubMed 19618202

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remote patient monitoring (Partnership for the Heart) in people with Chronic Heart Failure, run by Charite University, Berlin, Germany at 2 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 18 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 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

all cause mortality. 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 NCT00543881, which also lists 13 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 21 Dec 2016.

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