NCT06335264

Screening for Heart Failure Using a Multimodal Wearable Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find out if there are any patterns in the way people's bodies react to physical activities and their voices when they have heart failure, a disease where the heart cannot function sufficiently. To do this, the investigators will use a smartwatch that can measure multiple signals like the participant's heart rate and movement. Investigators will ask participants with and without heart failure to wear the Watch HOP (from HOP-Child Technologies Inc.) and sensors during physical tasks at their clinic visit at the McGill University Health Centre. Researchers will also record the participants' voices between their visits. The key signals can help find who is at risk for heart failure or develop new ways to monitor and treat it.

Detailed description

Heart Failure (HF) is a multi-faceted and life-threatening syndrome characterized by significant morbidity and mortality, poor functional capacity and quality of life, and high costs. Logistic and economic difficulties prove screening for HF challenging for some populations, such as people with reduced mobility and the elderly. Sensor technologies and data processing algorithms, including artificial intelligence, represent an opportunity to systematically identify patients suffering from HF as a complementary tool for echocardiography. The ability to compute digital biomarkers using complex models from wearable data requires identifying the key parameters that are associated with the presence of HF. A multisensorial wearable device can be utilized to develop digital biomarkers for population-based screening of HF. The present study aims to evaluate the best signals from a wearable device to identify digital signals (aka digital biomarkers) that are most associated with HF, including all ejection fraction types. For this study, investigators will recruit 27 participants with HF and 27 without HF. The primary objective of this study is to analyze the key physiological parameters recorded from the platform devices that can develop a digital biomarker for the presence of prevalent HF and its markers like NTproBNP, KCCQ, and 6MWD

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Watch HOP	A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App)

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-07-29
• Completion: 2025-08-31
• First posted: 2024-03-28
• Last updated: 2025-12-17

Locations

1 site across 1 country: Canada