Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Economics and Technology
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00543881
First received: October 11, 2007
Last updated: June 17, 2014
Last verified: June 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • all cause mortality [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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

Enrollment: 710
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Friedrich Koehler, Senior Physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00543881     History of Changes
Other Study ID Numbers: 01MG531
Study First Received: October 11, 2007
Last Updated: June 17, 2014
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 August 20, 2014