Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| HOP-Child Technologies Inc | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group (HF) |
i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40% |
| |
| Control group (non-HF) |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watch HOP | Device | A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App) |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of heart failure | the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Natriuretic peptide (NT-proBNP) level | A hormone molecule that plays a crucial role in the regulation of the cardiovascular system, used as a biomarker for heart failure. | baseline and at follow-up (up to 6 months after) |
| 6-minute walking distance (6MWD) |
Not provided
Inclusion Criteria:
Able to follow up with the study protocol schedule
Life expectancy > 1 year
Case group only
i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40%
Control group only
Exclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abhinav Sharma, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Distance measured during the standardized 6-minute walking test (6MWT) while the participant walks between 2 cones around 30 meters apart, measured by the coordinator with the count of complete and incomplete laps. |
| baseline and at follow-up (up to 6 months after) |
| Kansas City Cardiomyopathy Questionnaire Score (KCCQ) | 24-item multiple domain cardiomyopathy questionnaire, validated in the heart failure cohort to assess self-perceived symptoms and their effect on the participant's daily tasks. | baseline and at follow-up (up to 6 months after) |
| One-minute sit-to-stand repetitions | Amount of complete sit-to-stand repetitions during the 1MSTS test | baseline and at follow-up (up to 6 months after) |
| Left Ventricular Ejection Fraction (LVEF) | the ratio of stroke volume to left ventricular end-diastolic volume | baseline and at follow-up (up to 6 months after) |