Chronic Heart Failure
Conditions
Keywords
telemedicine, remote patient monitoring, chronic heart failure, mortality, health economics
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
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.
Interventions
DEVICERemote 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
DEVICEUsual care group
Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits
Sponsors
German Federal Ministry of Economics and Technology
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality | — |
Secondary
| Measure | 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 | — |
Countries
Germany
Outcome results
None listed