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Clinical Trials/DRKS00028195
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.

Registry
who.int
Start Date
May 3, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Charité- Campus Charité Mitte

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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