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Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00543881
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : December 21, 2016
Sponsor:
Collaborator:
German Federal Ministry of Economics and Technology
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany

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

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: Remote patient monitoring (Partnership for the Heart) Device: Usual care group Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemedical Interventional Monitoring in Heart Failure (TIM-HF)
Study Start Date : January 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1
Interventional group
Device: Remote patient monitoring (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
Other Name: brand name for remote patient monitoring system: Partnership for the Heart

Active Comparator: 2
Usual care group
Device: Usual care group
Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits




Primary Outcome Measures :
  1. all cause mortality

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ambulatory CHF NYHA II or III
  2. 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
  3. Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
  4. Age ≥ 18 years
  5. Informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543881


Locations
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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
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Principal Investigator: Friedrich Koehler, MD Charité - Universitaetsmedizin Berlin

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Friedrich Koehler, Senior Physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00543881     History of Changes
Other Study ID Numbers: 01MG531
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016

Keywords provided by Friedrich Koehler, Charite University, Berlin, Germany:
telemedicine
remote patient monitoring
chronic heart failure
mortality
health economics

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases