Screening for Heart Failure Using a Multimodal Wearable Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Presence or absence of heart failure
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Case group (HF)
- 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%
干预措施: Watch HOP (Device)
Control group (non-HF)
- Absence of known clinical heart failure history.
- Absence of criteria in the case group.
干预措施: Watch HOP (Device)
结局指标
主要结局
Presence or absence of heart failure
时间窗: up to 3 months, between two clinical visits
the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines
Presence or absence of heart failure
时间窗: baseline
the diagnosis of heart failure in the clinic based on the Canadian Heart Failure Society guidelines
次要结局
- Natriuretic peptide (NT-proBNP) level(baseline and at follow-up (up to 6 months after))
- 6-minute walking distance (6MWD)(baseline and at follow-up (up to 6 months after))
- Kansas City Cardiomyopathy Questionnaire Score (KCCQ)(baseline and at follow-up (up to 6 months after))
- One-minute sit-to-stand repetitions(baseline and at follow-up (up to 6 months after))
- Left Ventricular Ejection Fraction (LVEF)(baseline and at follow-up (up to 6 months after))
- 6-minute walking distance (6MWD)(up to 6 months, between two visits.)
- Natriuretic peptide (NT-proBNP) level(up to 6 months, between two clinical visits)
- Kansas City Cardiomyopathy Questionnaire Score (KCCQ)(up to 6 months, between two visits.)
研究者
Abhinav Sharma
Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre