NCT07447908

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 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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 Progress3%
Mar 2026Sep 2029

First Submitted

Initial submission to the registry

February 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Heart FailureHeart Failure - NYHA II - IVHeart Failure PatientsCardiopulmonary Exercise TestApple Watch

Keywords

Apple WatchCPETHeart FailureArtificial IntelligenceWearable TechnologyWearableRemote monitoring

Outcome Measures

Primary Outcomes (2)

  • Prediction of CPET parameters

    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

    7 months

  • 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

    7 months

Secondary Outcomes (3)

  • Prediction of CPET parameters

    7 months

  • Prediction of worsening HF as a combined and stratified outcome

    2 years

  • Prediction of existing markers of poor prognosis

    2 years

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult (\>18 years of age), ambulatory heart failure patients currently followed by the University Health Network and hospitals in multi-site validation study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southlake Health

Newmarket, Ontario, L3Y 2P9, Canada

Location

200 Elizabeth Street

Toronto, Ontario, M5G 2C4, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Heather Ross, MD

    University Health Network, Toronto

    STUDY CHAIR

  • Chris McIntosh, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Yasbanoo Moayedi, MD

    University Health Network - Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Li, MASc

CONTACT

6479669330ryan.li@uhn.ca

Ben Kim, PhD

CONTACT

ben.kim@uhn.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine Loretta Rogers Chair in Heart Function Site-Lead, Ted Rogers Centre for Heart Research

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 4, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations

CA(3)