Ted Rogers Understanding of Exacerbations in Heart Failure 2: Monitor (TRUE-HF 2)

February 25, 2026 updated by: Heather Ross, University Health Network, Toronto

Ted Rogers Understanding of Exacerbations in Heart Failure 2 (TRUE-HF2): Observational Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Traditionally, clinicians have relied on static snapshots of patients to determine clinical status and estimate prognosis. More advanced cardiac centres rely on CPET for objective prognosis. There is an unmet need for a more widely available, accessible, and longitudinal assessment of cardiopulmonary fitness and clinical status to better monitor and prognosticate patients. Wearable devices such as Apple Watch hold great promise in this regard, as they provide near-continuous monitoring of biometric data.

In TRUE-HF, we used Apple Watch data to build a novel model for serial daily prediction of cardiopulmonary fitness that is strongly correlated with CPET pVO2. In TRUE-HF2, we seek to prospectively validate the relationship between wearable data and changes in cardiopulmonary fitness, and early warnings of worsening heart failure as measured through decompensation, clinical deterioration, unplanned healthcare utilization, hospitalization, need for advanced heart failure therapies, and mortality.

The goal is to enable equitable access to cardiopulmonary fitness assessment for HF patients who may otherwise face significant barriers to tertiary-centre testing, including travel burden, geography, and limited local resources.

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 Questions:

  1. Can surrogates of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data predict significant reductions in cardiorespiratory fitness in heart failure patients?

  2. Can surrogates of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data predict early warnings of worsening heart failure?

    Secondary Research Questions:

  3. Can biometric data from Apple Watch in combination with clinical and/or demographical data be used to estimate cardiorespiratory fitness measurements and changes, as assessed by CPET?
  4. Can biometric data from Apple Watch in combination with clinical and/or demographical data from the Apple Watch be used to improve risk prediction models of worsening heart failure as combined (primary) or stratified (secondary) outcomes?
  5. Can biometric data from Apple Watch in combination with clinical and/or demographical data from the Apple Watch be used to predict markers of poor prognosis specifically as defined by the SHFM, BNP, Quality of life (QOL) indicators, and CPET parameters?

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
      • Toronto, Ontario, Canada
      • Toronto, Ontario, Canada, M5G 2C4
        • 200 Elizabeth Street
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yasbanoo Moayedi, MD
        • Principal Investigator:
          • Heather Ross, MD
        • Principal Investigator:
          • Chris McIntosh, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of CPET parameters
Time Frame: 7 months
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
Time Frame: 7 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of CPET parameters
Time Frame: 7 months
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 CPET
7 months
Prediction of worsening HF as a combined and stratified outcome
Time Frame: 2 years
Measure predictive power of biometric data obtained from Apple Watch in combination with clinical and/or demographical data against worsening heart failure
2 years
Prediction of existing markers of poor prognosis
Time Frame: 2 years
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?
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Study Chair: Heather Ross, MD, University Health Network, Toronto
  • Principal Investigator: Chris McIntosh, PhD, University Health Network, Toronto
  • Principal Investigator: Yasbanoo Moayedi, MD, University Health Network - Toronto General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-5233
  • 203992 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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