Wrist Wearables and AI Watch for Heart Failure Decline at Home
Tests AI analysis of wrist wearable data to spot early decline in advanced heart failure.
Plain-language title generated from the registry record
Registry title: Wearables and Artificial Intelligence in Advanced Heart Failure Care
Key facts
- Where
- Utrecht, NetherlandsSee the site
Where in Netherlands
- UMC UtrechtUtrecht, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UMC Utrecht
- Trial code
- NCT07051356
- Record updated
- 4 July 2025
- Original description
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.Read full original descriptionShow less
Advancing Proactive Care in Advanced Heart Failure: Integrating AI and Continuous Remote Monitoring for Early Detection of Heart Failure Deterioration
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.
Inclusion: >18 years; Diagnosis of advanced heart failure, including at least one of the following major criteria; LVAD implanted; Included on the waiting list for Heart transplant; Meeting the European Society of CArdiology criteria for advanced HF:; Severe and persistent symptoms of heart failure [NYHA class III or IV]; Severe cardiac dysfunction: according to ESC guidelines definition; ≥ 1 unplanned visit or hospitalization in the last 12 months requiring IV treatment; Have access to a mobile phone or tablet with an operating system iSO 15 or Android 9 (or posterior versions of these systems).
Exclusion: Impossibility to provide inform consent; Impossibility to self-report data due to physical or mental disability.