NCT07051356Not yet recruiting
Wearables and Artificial Intelligence in Advanced Heart Failure Care
Advancing Proactive Care in Advanced Heart Failure: Integrating AI and Continuous Remote Monitoring for Early Detection of Heart Failure Deterioration
Source: ClinicalTrials.gov · Last updated 4 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 26 May 2025
- Start date
- Jul 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- UMC Utrecht
- Diseases
- Heart failure
- NCT number
- NCT07051356
What you commit to
- Study type: Observational
- Planned participants: 200
- From Jul 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Impossibility to provide inform consent.
- Impossibility to self-report data due to physical or mental disability.
Who the study is looking for
- \>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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.