Telemedical Interventional Monitoring in Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Device: Remote patient monitoring (Partnership for the Heart)
* Device: Usual care group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Interventional group | Device: Remote patient monitoring (Partnership for the Heart)<br>* 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<br>* Other names: brand name for remote patient monitoring system: Partnership for the Heart;|
| Active Comparator: 2<br>Usual care group | Device: Usual care group<br>* Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, remote patient monitoring, chronic heart failure, mortality, health economics