Telemedical Interventional Management in Heart Failure II
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 1571
- Locations
- 107
- Primary Endpoint
- Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Superiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:
- days lost due to unplanned cardiovascular hospitalization or death
- all-cause mortality
- cardiovascular mortality
- quality of life
Detailed Description
The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) 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.
Investigators
Friedrich Koehler
Prof. Dr. Friedrich Koehler, MD, Senior Physician
Charite University, Berlin, Germany
Eligibility Criteria
Inclusion Criteria
- •chronic heart failure New York Heart Association (NYHA) class II or III
- •echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or \>45% + minimum 1 diuretic in permanent medicinal therapy
- •hospitalization due to decompensated HF within the last 12months before randomization
- •informed consent
- •Depression score PHQ-9: \<10
Exclusion Criteria
- •hospitalization within the last 7 days before randomization
- •implanted cardiac assist system
- •acute coronary syndrome within the last 7 days before randomization
- •high urgent listed for heart transplantation (HTx)
- •planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
- •revascularization and/or CRT-implantation within 28 days before randomization
- •known alcohol or drug abuse
- •terminal renal insufficiency with hemodialysis
- •impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
- •existence of any disease reducing life expectancy to less than 1 year
Outcomes
Primary Outcomes
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time.
Time Frame: 12 months/ individual-patient follow-up time.
The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.
Secondary Outcomes
- Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time(12 months/ individual follow-up time)
- Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.(12 months/ individual follow-up time)
- Change in MLHFQ-questionnaire overall score between baseline and 365 days(12 months/ individual follow-up time)
- Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days.(12 months/ individual follow-up time)
- All-cause mortality during the individual patient follow-up time.(individual patient follow-up time (+28 days of the final visit to a maximum 393 days))