Status:
COMPLETED
CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring
Lead Sponsor:
Eckhard Nagel
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change...
Detailed Description
Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitor...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Chronic Heart Failure (CHF) based on European Society of Cardiology (ESC) guidelines
- Symptoms corresponding to New York Heart Association (NYHA) functional class II-IV
- Left Ventricular Ejection Fraction (LVEF) ≤ 40%
- American Heart Association (AHA) classification stage C or D
- Age \> 18 years
- Discharged after hospitalisation for worsening Chronic Heart Failure (CHF) within the last twelve months
- Able to understand the German language
- Sufficient eyesight to understand and follow the instructions communicated by the Motiva® platform
- Willing and able to use the required hard- and software and maintain a patient diary
- Residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation
- Willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform Motiva®
Exclusion
- Myocardial infarction within the past four weeks
- Heart surgery or any coronary intervention within the past eight weeks
- Cardiogenic shock within the past four weeks
- Intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation
- Severe chronic and pulmonary illness with an immediate impact on the main outcome measures
- Renal failure requiring dialysis
- Dementia or other severe cognitive impairment
- Psychiatric disorders rendering patients unable to participate in the trial
- Discharged to or living in a geriatric clinic or a nursing home
- Participation in another clinical trial
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT02293252
Start Date
March 1 2009
End Date
October 1 2016
Last Update
October 25 2016
Active Locations (1)
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1
University of Bayreuth
Bayreuth, Bavaria, Germany, 95444