Screening for Heart Failure Using a Multimodal Wearable Device

NCT06335264 | Completed DMC

• 1 other identifier: 2024-9987
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Wearable; Digital biomarker; Heart rate variability; 6-minute walking test; Voice biomarker

Outcome Measures

Primary Outcomes (1)

• Presence or absence of heart failure

  the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines

  up to 3 months, between two clinical visits

Secondary Outcomes (3)

• Natriuretic peptide (NT-proBNP) level

  up to 6 months, between two clinical visits

• 6-minute walking distance (6MWD)

  up to 6 months, between two visits.

• Kansas City Cardiomyopathy Questionnaire Score (KCCQ)

  up to 6 months, between two visits.

Study Arms (2)

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%

Device: Watch HOP

Control group (non-HF)

1. Absence of known clinical heart failure history. 2. Absence of criteria in the case group.

Device: Watch HOP

Interventions

Watch HOP DEVICE

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

Case group (HF); Control group (non-HF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Case group will be enrolled from the cardiology clinics at the Royal Victoria Hospital (located at MUHC). Patients will be screened for on the clinic lists on a daily basis. The attending physician will be asked if the patient is suitable for enrollment. The participant will be approached, and the informed consent will be taken before enrollment. 2. Control group will be recruited from both the cardiology clinics (patients without heart failure) and Cortois Cardiovascular Signature Program, also at the Royal Victoria Hospital. Patients will be screened for on the clinic lists on a daily basis. The attending physician will be asked if the patient is suitable for enrollment. The participant will be approached, and the informed consent will be taken before enrollment.

You may qualify if:

• Able to follow up with the study protocol schedule
• Life expectancy \> 1 year
• Case group only
• 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
• NT-proBNP levels \> 125 pg/L or objective evidence of cardiogenic pulmonary or systemic congestion
• One of the following;
• i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40%
• Control group only
• Absence of known clinical heart failure history.
• Absence of criteria above in the case group.

You may not qualify if:

• Any person who does not meet the above criteria or who refuses to participate
• Undergoing chemotherapy or dialysis
• In addition, the following list of criteria are specific to accurate wrist wearable measurements:
• Skin burns or rashes on the measurement locations (wrist for wearable, finger for oximeter, chest for Polar ECG)
• Patients with tremors
• Recent use of dermatological creams, ointments, or lotions at the recording area

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• HOP-Child Technologies Inc: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Abhinav Sharma, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 28, 2024
• Study Start: January 15, 2024
• Primary Completion: July 29, 2025
• Study Completion: August 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)