DRKS00028195
Recruiting
Not Applicable
Collection of telemedical data from patients with chronic heart failure for a post-hoc analysis of an AI approach to vital signs processing (short title: Telemed5000-HF) - Telemed5000-HF
Charité- Campus Charité Mitte0 sites100 target enrollmentMay 3, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- I50
- Sponsor
- Charité- Campus Charité Mitte
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. patients with chronic heart failure in NYHA class II or III.
- •2\. echocardiographically determined left ventricular ejection fraction (LVEF) \=45% or LVEF \>45% \+ at least 1 diuretic in long\-term medical therapy.
- •3\. have been hospitalised for cardiac decompensation\<12 months prior to inclusion in the study (not related to a proven myocardial infarction without pre\-existing moderately restricted LVEF) (doctor's letter available).
- •4\. no moderate or severe depression
- •5\. written informed consent of the patient
Exclusion Criteria
- •1\. hospitalisation within the last 7 days before study start (exept due to cardiac decompensation)
- •2\. condition after implantation of a mechanical cardiac assist system
- •3\. acute coronary syndrome within the last 7 days before study inclusion
- •4\. high urgent HTX listing
- •5\. planned revascularisation, TAVI, mitraclip and/or CRT implantation within 3 months of study inclusion
- •6\. revascularisation and/or CRT implantation within 3 months prior to study inclusion
- •7\. chronic drug or alcohol abuse as assessed by the physician
- •8\. terminal renal failure with haemodialysis treatment
- •9\. inability or unwillingness to perform telemonitoring (e.g. dementia, blindness, deafness, wheelchair use, insufficient knowledge of German, speech or voice disorders affecting voice analysis, limited informal self\-determination)
- •10\. illnesses with a life expectancy\<12 months
Outcomes
Primary Outcomes
Not specified
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