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Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation

N

Nisha Arenja

Status

Not yet enrolling

Conditions

Heart Failure

Treatments

Device: Ambient sensor system

Study type

Interventional

Funder types

Other

Identifiers

NCT06126848
eHealth-HF

Details and patient eligibility

About

Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.

Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)

Enrollment

24 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • admitted to hospital for worsening HF
  • age ≥ 70 years
  • LVEF < 50% and need of diuretics
  • NYHA II or III
  • living alone
  • willing to participate with informed consent.

Exclusion criteria

  • Major depression (PHQ 9-score >9)
  • being on hemodialysis
  • had been admitted to hospital for any reason within 7 days before HF decompensation.
  • patients with a left ventricular assist device
  • coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Observation Cohort
Other group
Treatment:
Device: Ambient sensor system

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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