Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT07051356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wearables and Artificial Intelligence in Advanced Heart Failure Care
Sponsor:
UMC Utrecht
Organization:
Study Overview
Official Title:
Advancing Proactive Care in Advanced Heart Failure: Integrating AI and Continuous Remote Monitoring for Early Detection of Heart Failure Deterioration
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WAI-HF
Brief 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.
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.
Detailed Description:
Advanced heart failure (HF) is characterized by persistent and progressive symptoms despite optimal, guideline-directed medical therapy. Although improvements in care have been achieved, mortality remains high, and recurrent hospitalizations continue to significantly impact patients' morbidity and quality of life. Timely recognition of early signs of clinical deterioration remains a challenge. Innovative approaches that enable early identification of patients at increased risk of readmission may support proactive interventions and help reduce the need for hospitalization.
In the WAI-HF study, we will investigate whether AI-driven analysis wearable data can identify changes that precede hospital admission in patients with advanced heart failure. The wrist-worn device measures several physiological parameters including heart rate, heart rate variability, respiratory rate, skin temperature, 1-lead electrocardiogram, and sleep quality. Data collected in the remote monitoring including continuous data derived from the wearable device and symptomatic data collected in the eHealth app, will be used to develop a predictive model.
The study will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013), to 'gedragscode gezondheidsonderzoek', and in accordance with the EU GDPR (General Data Protection Regulation).
In the WAI-HF study, we will investigate whether AI-driven analysis wearable data can identify changes that precede hospital admission in patients with advanced heart failure. The wrist-worn device measures several physiological parameters including heart rate, heart rate variability, respiratory rate, skin temperature, 1-lead electrocardiogram, and sleep quality. Data collected in the remote monitoring including continuous data derived from the wearable device and symptomatic data collected in the eHealth app, will be used to develop a predictive model.
The study will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013), to 'gedragscode gezondheidsonderzoek', and in accordance with the EU GDPR (General Data Protection Regulation).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: