Telemedical Interventional Monitoring in Heart Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

October 11, 2007

Last Updated Date

November 27, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall Mortality [ Time Frame: 1 year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00543881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Telemedical Interventional Monitoring in Heart Failure

Official Title ^ICMJE

Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Brief 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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Health Services Research

Condition ^ICMJE

Chronic Heart Failure

Intervention ^ICMJE

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

Other Name: brand name for remote patient monitoring system: Partnership for the Heart
Device: Usual care group
Guideline-based care in heart failure (NYHA II-III) including 5 scheduled doctor's visits

Study Arms / Comparison Groups

1: Experimental
Interventional group

Intervention: Device: Remote patient monitoring (Partnership for the Heart)
2: Active Comparator
Usual care group

Intervention: Device: Usual care group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

710

Estimated Completion Date

October 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00543881

Responsible Party

Study ID Numbers ^ICMJE

01MG532

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

German Federal Ministry of Economics and Technology

Investigators ^ICMJE

Principal Investigator:

Friedrich Koehler, MD

Charité - Universitaetsmedizin Berlin

Information Provided By

Charite University, Berlin, Germany

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP