Ted Rogers Understanding of Exacerbations in Heart Failure 2: Monitor

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

360 Participants
are grouped into 4 trial groups
Group A: UHN Patients
Group B: Southlake Health Patients
Group C: Sunnybrook Patients
Group D: Peterborough Regional Health Center Patients

Trial outcomes

Primary outcomes

1

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

Time frame
7 months
2

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.

Time frame
7 months

Secondary outcomes

1

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.

Time frame
7 months
2

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

Time frame
2 years
3

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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University Health Network, Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator