Recruiting

Heart Failure

Sponsor:

University Health Network, Toronto

Code:

NCT05008692

Conditions

Heart Failure

Heart Failure, Systolic

Heart Failure, Diastolic

Heart Transplantation

Heart Failure，Congestive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Heart Failure

Heart Failure, Systolic

Heart Failure, Diastolic

Heart Transplantation

Heart Failure，Congestive

Study ID

NCT05008692

Start date

Dec 1, 2020

Status verified date

Nov, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Apple Watch metrics prediction of CPET parameters [ Time Frame: 3 months ]
  • 6 minute walk test [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Enza De Luca, RN

416-340-4800enza.deluca@uhn.ca

Ben Kim, PhD

416-340-4800ben.kim@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Enza De Luca, RN

416-340-4800enza.deluca@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 16, 2022

Last verified

Nov, 2022

Keywords

  • Wearable
  • Apple Watch
  • Cardiopulmonary Exercise Test
  • 6MWT
  • Biomarker
  • peak VO2
  • Patient Reported Outcomes
  • QOL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2022-11-16.