Ted Rogers Understanding of Exacerbations in Heart Failure 2 (TRUE-HF2): Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Prediction of worsening heart failure
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 multicentre study will validate 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 outpatient HF population.
详细描述
Traditionally, clinicians have relied on static snapshots of patients to determine clinical status and estimate prognosis. More advanced cardiac centres rely on CPET for objective prognosis. There is an unmet need for a more widely available, accessible, and longitudinal assessment of cardiopulmonary fitness and clinical status to better monitor and prognosticate patients. Wearable devices such as Apple Watch hold great promise in this regard, as they provide near-continuous monitoring of biometric data.
In TRUE-HF, we used Apple Watch data to build a novel model for serial daily prediction of cardiopulmonary fitness that is strongly correlated with CPET pVO2. In TRUE-HF2, we seek to prospectively validate the relationship between wearable data and changes in cardiopulmonary fitness, and early warnings of worsening heart failure as measured through decompensation, clinical deterioration, unplanned healthcare utilization, hospitalization, need for advanced heart failure therapies, and mortality.
The goal is to enable equitable access to cardiopulmonary fitness assessment for HF patients who may otherwise face significant barriers to tertiary-centre testing, including travel burden, geography, and limited local resources.
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 Questions:
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 (> 18 years of age)
- •NT-proBNP > 400 or 1000 if in AF
- •Within 3 months post discharge from HF hospitalization/ HF ED visit/ HF rapid clinic visit with intensification of diuretic therapy
- •NYHA functional class I-IV, heart failure with reduced and preserved ejection fraction
- •Literacy in English
- •Patient provided informed consent
排除标准
- •Unable to perform a CPET based on the standard protocol
- •End stage renal disease requiring dialysis
- •Living with LVAD
- •MRP deems patient unfit for the study
- •Post heart transplant
研究组 & 干预措施
UHN Patients
Heart failure patients followed at UHN
Southlake Health Patients
Heart failure patients followed at Southlake Health
Sunnybrook Patients
Heart failure patients followed at Sunnybrook
Peterborough Regional Health Center Patients
Heart failure patients followed at Peterborough Regional Health Center
结局指标
主要结局
Prediction of worsening heart failure
时间窗: 7 months
Measure predictive power of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data against worsening heart failure from clinical visits, bloodwork, and medication changes.
Prediction of Cardiopulmonary Exercise Test Parameters
时间窗: 7 months
Measure the predictive power of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data against reductions in measured cardiorespiratory fitness, using K5 device in heart failure patients
Prediction of CPET parameters
时间窗: 7 months
Measure predictive power of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data against reductions in measures of cardiorespiratory fitness in heart failure patients such as peak VO2
次要结局
- Prediction of existing markers of poor prognosis(2 years)
- Prediction of Cardiopulmonary Exercise Test Parameters(7 months)
- Prediction of worsening Heart Failure as a combined and stratified outcome(2 years)
- Prediction of CPET parameters(7 months)
- Prediction of worsening HF as a combined and stratified outcome(2 years)
研究者
Heather Ross
Professor of Medicine Loretta Rogers Chair in Heart Function Site-Lead, Ted Rogers Centre for Heart Research
University Health Network, Toronto