Apple-CPET Ted Rogers Understanding Exacerbations of Heart Failure
TRUE-HF
Measuring Cardiopulmonary Fitness in Ambulatory Heart Failure Patients Through the Use of Apple Watch Features
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 24, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 16, 2022
November 1, 2022
2.6 years
July 24, 2021
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Apple Watch metrics prediction of CPET parameters
Measure predictive power of Apple Watch metrics such as heart rate against CPET parameters such as peak VO2
3 months
6 minute walk test
Correlation of Apple 6MW estimate with measured 6MWT
3 months
Secondary Outcomes (3)
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
Eligibility Criteria
Adult (\>17 years of age), ambulatory heart failure patients currently followed by the University Health Network.
You may qualify if:
- 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
You may not qualify if:
- \- Physical disability that prevents exercise testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Apple Inc.collaborator
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Related Publications (1)
Moayedi Y, Foroutan F, Gao Y, Kim B, De Luca E, Brum M, Brahmbhatt DH, Duhamel J, Simard A, McIntosh C, Ross HJ. Developments in Digital Wearable in Heart Failure and the Rationale for the Design of TRUE-HF (Ted Rogers Understanding of Exacerbations in Heart Failure) Apple CPET Study. Circ Heart Fail. 2025 Jun;18(6):e012204. doi: 10.1161/CIRCHEARTFAILURE.124.012204. Epub 2025 May 9.
PMID: 40340421DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather J Ross, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Division of Cardiology
Study Record Dates
First Submitted
July 24, 2021
First Posted
August 17, 2021
Study Start
December 1, 2020
Primary Completion
July 1, 2023
Study Completion
December 1, 2023
Last Updated
November 16, 2022
Record last verified: 2022-11