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

NCT06126848 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-11-14

No results posted yet for this study

Summary

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)

Conditions

Interventions

DEVICE

Ambient sensor system

Main study: A contactless non-intrusive ambient sensor system including infrared motion sensors combined with a contactless Emfit bed sensor will be installed in the home of single living study patients by using a commercially available System (Domo Health®, Lausanne) after informed consent has been obtained. Sensor data are prospectively followed over 3-6 months for predefined indicators of health deterioration. If indicators for health deterioration are present, patients will be called in to the hospital for cardiology consult by the study team including blood analysis for follow-up of BNP values and if necessary, therapy adaption.

Sponsors & Collaborators

  • Nisha Arenja

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2025-12-31
Completion
2026-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126848 on ClinicalTrials.gov