Telemedical Interventional Monitoring in Heart Failure

Charite University, Berlin, Germany710 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

710

Conditions

Chronic Heart Failure

Interventions

Remote patient monitoring (Partnership for the Heart)DEVICE

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

Usual care groupDEVICE

Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Charité - Universitaetsmedizin Berlin

Berlin, Germany

Robert-Bosch-Krankenhaus

Stuttgart, Germany

Outcomes

Primary Outcomes

all cause mortality

Secondary Outcomes

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

Data from ClinicalTrials.gov

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