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Wearables and Artificial Intelligence in Advanced Heart Failure Care

NCT07051356 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-07-04

No results posted yet for this study

Summary

The goal of this observational study is to evaluate whether AI-based analyses of wearable sensor data can identify early signs of deterioration leading to hospitalization in patients with advanced heart failure.

The main questions it aims to answer are:

* Can AI-driven analysis of wearable data detect physiological or behavioral changes associated with impending hospital admissions?
* Does wearable-based remote monitoring influence daily exercise duration in patients with advanced heart failure.
* Is wearable-based remote monitoring usable and acceptable for patients with advanced heart failure in a real-world setting?

Participants will wear a wrist-worn (Fitbit) device continuously for one year and will use an eHealth app to answer question about their symptoms. Participant's physical activity, heart rate, heart rate variability, respiratory rate, sleep quality, and symptomatic status will be monitored remotely.

Conditions

  • Advanced Heart Failure

Sponsors & Collaborators

  • Health Holland

    collaborator OTHER

  • Viduet Health

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Netherlands

Study Locations

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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 NCT07051356 on ClinicalTrials.gov