Telemedical Interventional Monitoring in Heart Failure

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.

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