Telemedical Interventional Monitoring in Heart Failure (TIM-HF)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
Collaborator:
German Federal Ministry of Economics and Technology
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00543881
First received: October 11, 2007
Last updated: November 4, 2010
Last verified: November 2009
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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:
- 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
Exclusion Criteria:
- 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
- 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
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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00543881 History of Changes |
| Other Study ID Numbers: | 01MG532 |
| Study First Received: | October 11, 2007 |
| Last Updated: | November 4, 2010 |
| 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 May 22, 2013