McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
NCT Number: NCT06335264
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.
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Notify Me18 year and older
All sexes
Observational
Montreal, Quebec, H4A 3J1, Canada
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
i. For HFpEF, LVEF ≥ 50% ii. For HFmrEF, LVEF 41-49% iii. For HFrEF, LVEF ≤ 40%
Exclusion criteria
A multisensorial wearable smartwatch that measures actigraphy (motion), skin temperature, heart rate variability (PPG), electrodermal activity, and voice (via App)
Time frame: baseline
the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines
Time frame: baseline and at follow-up (up to 6 months after)
A hormone molecule that plays a crucial role in the regulation of the cardiovascular system, used as a biomarker for heart failure.
Time frame: baseline and at follow-up (up to 6 months after)
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.
Time frame: baseline and at follow-up (up to 6 months after)
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.
Time frame: baseline and at follow-up (up to 6 months after)
Amount of complete sit-to-stand repetitions during the 1MSTS test
Time frame: baseline and at follow-up (up to 6 months after)
the ratio of stroke volume to left ventricular end-diastolic volume
McGill University Health Centre/Research Institute of the McGill University Health Centre
Other
Acronym: WEAR-HF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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