Measuring Cardiopulmonary Fitness in Ambulatory Heart Failure Patients Through the Use of Apple Watch Features
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Apple Watch metrics prediction of CPET parameters
研究概览
简要总结
Heart Failure (HF) is a complex disease associated with the highest burden of cost to the healthcare system. The cardiopulmonary exercise test (CPET) is instrumental in determining the prognosis of patients with HF. This study will evaluate whether aggregate biometric data from the Apple Watch combined with demographic, cardiac, and biomarker testing can improve our ability to predict heart failure outcomes among a diverse ambulatory HF population
详细描述
Heart Failure (HF) has a prevalence of 3.5% suggesting that over one million Canadians are affected by this disease, and more than 50,000 are newly diagnosed each year. This complex disease is associated with the highest burden of cost to the healthcare system, attributable to hospitalizations, missed work, medications, and health care services
Traditionally, clinicians have relied on static snapshots of patients to determine clinical status and estimate prognosis. More advanced cardiac centers rely on cardiopulmonary exercise testing (CPET), where patients are further stratified based on validated exercise parameters. CPET remains underutilized and resource-intensive. It requires expensive equipment, proficient personnel, and clinicians with specialized training. Thus, there is an unmet need for a more widely available, accessible, and longitudinal assessment of clinical status to better monitor and prognosticate patients outside of the ambulatory setting. Wearable devices such as the Apple Watch hold great promise in this regard, as they provide near-continuous monitoring of biometric data. By combining biometric data with demographic, cardiac, and biomarker testing, the investigators will significantly improve our ability to predict heart failure outcomes such as early warning of decompensation, clinical deterioration (symptoms and brain natriuretic peptide (BNP) as a surrogate), hospitalization, mortality (using the Seattle Heart Failure Model (SHFM) as a surrogate), and/or need for advanced heart failure therapies.
Our study has 5 research questions based on 2 primary outcomes and 3 secondary outcomes in clinically diverse adult ambulatory heart failure patients :
Primary Research Question:
- Can biometric data obtained from the Apple Watch be used to estimate cardiorespiratory fitness, as assessed by CPET?
- Does the 'predicted' Apple 6 MW estimate correlate with formal 6 MWT?
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
- 否
入选标准
- •broad age range (> 17 years of age)
- •diverse races/ethnicities,
- •equal female and male representation,
- •NYHA functional class I-IV, heart failure with reduced and preserved ejection fraction
- •Physical disability that prevents exercise testing
排除标准
- 未提供
结局指标
主要结局
Apple Watch metrics prediction of CPET parameters
时间窗: 3 months
Measure predictive power of Apple Watch metrics such as heart rate against CPET parameters such as peak VO2
6 minute walk test
时间窗: 3 months
Correlation of Apple 6MW estimate with measured 6MWT
次要结局
- Apple Watch sensors and markers of poor prognosis(3 months)
- Apple Watch Sensors and unscheduled visits(3 months)
- Biomarkers and digital signatures as a predictor of composite rehospitalisation, advanced therapies and mortality(2 years)
研究者
Heather Ross
Chief Division of Cardiology
University Health Network, Toronto