Screening for Heart Failure Using a Multimodal Wearable Device

NCT ID: NCT06335264

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2025-08-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Case group (HF)

1. Clinical signs and/or symptoms of heart failure caused by a structural and/or functional cardiac abnormality, as defined by Bozkurt et al. [2021], diagnosed at the cardiovascular clinic

2. NT-proBNP levels > 125 pg/L or objective evidence of cardiogenic pulmonary or systemic congestion

3. One of the following;

i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40%

Watch HOP

Intervention Type: DEVICE

A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App)

Control group (non-HF)

1. Absence of known clinical heart failure history.

2. Absence of criteria in the case group.

Watch HOP

Intervention Type: DEVICE

A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App)

Interventions

Watch HOP

A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Able to follow up with the study protocol schedule

2. Life expectancy > 1 year

3. Case group only

1. Clinical signs and/or symptoms of heart failure caused by a structural and/or functional cardiac abnormality, as defined by Bozkurt et al. [2021], diagnosed at the cardiovascular clinic

2. NT-proBNP levels > 125 pg/L or objective evidence of cardiogenic pulmonary or systemic congestion

3. One of the following;

i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40%

4. Control group only

1. Absence of known clinical heart failure history.

2. Absence of criteria above in the case group.

Exclusion Criteria

1. Any person who does not meet the above criteria or who refuses to participate

2. Undergoing chemotherapy or dialysis

3. In addition, the following list of criteria are specific to accurate wrist wearable measurements:

1. Skin burns or rashes on the measurement locations (wrist for wearable, finger for oximeter, chest for Polar ECG)

2. Patients with tremors

3. Recent use of dermatological creams, ointments, or lotions at the recording area

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HOP-Child Technologies Inc

UNKNOWN

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Abhinav Sharma

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abhinav Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2024-9987

Identifier Type: -

Identifier Source: org_study_id