Telemedical Interventional Monitoring in Heart Failure - Full Text View

Sponsor:	Charite University, Berlin, Germany
Collaborator:	German Federal Ministry of Economics and Technology
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00543881

Purpose

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

Condition	Intervention	Phase
Chronic Heart Failure	Device: Remote patient monitoring (Partnership for the Heart) Device: Usual care group	Phase III

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Overall Mortality [ Time Frame: 1 year ]

Secondary Outcome Measures:

Days alive and out of hospital due to heart failure cardiovascular mortality sudden death overall hospitalization cardiovascular hospitalization quality of life health economics [ Time Frame: 1 year ]

Enrollment:	710
Study Start Date:	January 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Interventional group	Device: Remote patient monitoring (Partnership for the Heart) Guideline-based care in heart failure (NYHA II-III) including 5 scheduled doctor's visits plus daily monitoring of ECG, weight, blood pressure, self-report of health status, weekly monitoring of physical fitness
2: Active Comparator Usual care group	Device: Usual care group Guideline-based care in heart failure (NYHA II-III) including 5 scheduled doctor's visits

Detailed Description:

The clinical trial assesses 710 patients over a period of 15 months (January 2008 until May 2009); 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. 300 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

NYHA II-III
Ejection fraction < 35%
At least one hospitalization due to heart failure after 2006/01/01 and/or administration of iv diuretics

Exclusion Criteria:

Life expectancy < 1 year due to other diseases
Chronic renal insufficiency (Crea > 2.5 mg)
Mentally disabled
Instable angina pectoris
Listing for any kind of transplantation
Pregnancy
Chronic drug and/or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543881

Locations

Germany
Charité - Universitaetsmedizin Berlin
Berlin, Germany, 10117
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376

Sponsors and Collaborators

Charite University, Berlin, Germany

German Federal Ministry of Economics and Technology

Investigators

Principal Investigator:

Friedrich Koehler, MD

Charité - Universitaetsmedizin Berlin

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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. Epub 2006 Jul 24. No abstract available.

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. German. No abstract available.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Jehn M, Halle M, Schuster T, Hanssen H, Weis M, Koehler F, Schmidt-Trucksäss 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. Epub 2009 Jul 18.

Study ID Numbers:	01MG532
Study First Received:	October 11, 2007
Last Updated:	November 27, 2009
ClinicalTrials.gov Identifier:	NCT00543881 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

telemedicine
remote patient monitoring
chronic heart failure
mortality
health economics

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010