Using a wearable device to screen for heart failure
Screening for Heart Failure Using a Multimodal Wearable Device
McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06335264
This study is testing a smartwatch that tracks heart rate and movement, along with voice recordings, to see if it can help find signs of heart failure in people.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06335264 on ClinicalTrials.gov |
What this trial studies
This study aims to identify patterns in physiological responses and voice characteristics in individuals with heart failure using a multimodal wearable device. Participants will wear the Watch HOP smartwatch, which measures heart rate and movement, during physical activities at the McGill University Health Centre. Additionally, voice recordings will be collected to analyze potential digital biomarkers associated with heart failure. The goal is to develop effective screening tools for heart failure that can complement traditional diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with heart failure and those without a history of heart failure for comparison.
Not a fit: Patients currently undergoing chemotherapy or dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and better management of heart failure, improving patient outcomes.
How similar studies have performed: While the use of wearable devices for health monitoring is gaining traction, this specific approach to screening for heart failure using multimodal data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- McGill University Health Centre — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Abhinav Sharma, MD — McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study coordinator: Abhinav Sharma, MD
- Email: abhinav.sharma@mcgill.ca
- Phone: 5149341934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Wearable, Digital biomarker, Heart rate variability, 6-minute walking test, Voice biomarker