Clinical trial Recruiting at 1 site Observational Ages 18 and up

Understanding Exacerbations in Heart Failure: Monitoring with Apple Watch

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

Run by University Health Network, Toronto · NCT07447908 · Data updated 2026-11-12

This study tests whether data from an Apple Watch, combined with clinical information, can help predict worsening heart failure in adults living with the condition.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment360 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations3 sites (Newmarket, Ontario and 2 other locations)
StatusRecruiting
StartedJune 16, 2026
Main results expectedSeptember 2029
Study endsSeptember 2029
Registry record updatedJuly 6, 2026
Trial IDNCT07447908 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 with heart failure (NYHA I-IV), regardless of ejection fraction, who recently had a heart failure-related hospital or ED event and can use English, with consent.

Probably not a fit

Patients unable to perform CPET per protocol, those with end-stage renal disease on dialysis, LVAD recipients, or those deemed unfit by the study team may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to validate whether wearable-derived biometric data, together with demographic, cardiac, and biomarker information, can improve prediction of heart failure outcomes. Building on prior work with Apple Watch data, the study seeks to correlate continuous wearable signals with changes in cardiopulmonary fitness and early signs of decompensation. The goal is to enable accessible, longitudinal monitoring of cardiopulmonary status for diverse outpatient heart failure patients, potentially reducing the need for tertiary-center CPET testing. Enrollment includes adults with various stages of heart failure, including both reduced and preserved ejection fraction, who recently experienced hospitalization or diuretic therapy intensification. Primary and secondary outcomes focus on fitness surrogates, clinical deterioration, hospital utilization, and mortality, analyzed across multiple centers in Canada.

Why it matters

Potential benefit: If successful, patients could receive earlier detection of worsening heart failure and more timely interventions through a noninvasive, wearable-based monitoring approach.

How similar studies have gone: Prior work suggests wearable data can reflect cardiopulmonary status, but prospective validation in diverse outpatient HF populations is ongoing and valuable.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • 200 Elizabeth Street
    Toronto, Ontario, Canada
    Recruiting
  • Southlake Health
    Newmarket, Ontario, Canada
    Not yet recruiting
  • Sunnybrook Health Sciences Center
    Toronto, Ontario, Canada
    Not yet recruiting

Study contacts

  • Principal investigator: Chris McIntosh, PhD — University Health Network, Toronto
  • Study coordinator: Ryan Li, MASc
  • Email: ryan.li@uhn.ca
  • Phone: 6479669330

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.