About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult (\>18 years of age), ambulatory heart failure patients currently followed by the University Health Network and hospitals in multi-site validation study.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prediction of Cardiopulmonary Exercise Test Parameters
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 worsening heart failure
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.
Secondary outcomes
Prediction of Cardiopulmonary Exercise Test Parameters
Measure predictive power of biometric data obtained from Apple Watch in combination with clinical and/or demographical data against cardiorespiratory fitness measurements as assessed by Cardiopulmonary Exercise Test using a K5 device.
Prediction of worsening Heart Failure as a combined and stratified outcome
Measure predictive power of biometric data obtained from Apple Watch in combination with clinical and/or demographical data against worsening heart failure
Prediction of existing markers of poor prognosis
Measure predictive power of biometric data obtained from Apple Watch in combination with clinical and/or demographical data from the Apple Watch be against existing markers of poor prognosis specifically as defined by the SHFM, BNP, Quality of life (QOL) indicators, and CPET parameters as measured by K5 device
Sponsors and contacts
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University Health Network, Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator