Clinical trial NCT05008692: Apple-CPET Ted Rogers Understanding Exacerbations of Heart Failure
Official title: Measuring Cardiopulmonary Fitness in Ambulatory Heart Failure Patients Through the Use of Apple Watch Features
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Heart Failure, Systolic
Heart Failure, Diastolic
Heart Transplantation
Heart Failure，Congestive
Keywords: Wearable
Apple Watch
Cardiopulmonary Exercise Test
6MWT
Biomarker
peak VO2
Patient Reported Outcomes
QOL
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Apple Inc.
First posted: 2021-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (\>17 years of age), ambulatory heart failure patients currently followed by the University Health Network.

Brief summary: 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

Detailed description: 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:

1. Can biometric data obtained from the Apple Watch be used to estimate cardiorespiratory fitness, as assessed by CPET?
2. Does the 'predicted' Apple 6 MW estimate correlate with formal 6 MWT?

   Secondary Research Questions:
3. Is there a relationship between novel biosensors, including oxygen saturation, and markers of poor prognosis specifically as defined by the SHFM, BNP, Quality of life (QOL) indicators, and CPET parameters?
4. Can surrogates of cardiorespiratory fitness obtained from the Apple Watch, including novel biosensors, predict acute decompensation of heart failure as defined rapid clinic visits, need for IV diuretics, ED visits, heart failure hospitalization and unscheduled health care encounters during the 3-month follow-up?
5. Can biometric data be used to improve a risk prediction model that can distinguish between patients at high versus low risk of all-cause hospitalization (primary outcome), all-cause mortality (secondary outcome), and a composite outcome of all-cause mortality, need for ventricular assist device, or heart transplantation (secondary composite outcome) over a 2 year period?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion

- Physical disability that prevents exercise testing

Primary outcomes:
measure: Apple Watch metrics prediction of CPET parameters
timeFrame: 3 months
measure: 6 minute walk test
timeFrame: 3 months
Secondary outcomes:
measure: Apple Watch sensors and markers of poor prognosis
timeFrame: 3 months
measure: Apple Watch Sensors and unscheduled visits
timeFrame: 3 months
measure: Biomarkers and digital signatures as a predictor of composite rehospitalisation, advanced therapies and mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Heather J Ross, MD
role: PRINCIPAL_INVESTIGATOR
References: