Heart FailureTRUE-HF 2NCT07447908
Ted Rogers Understanding of Exacerbations in Heart Failure 2: Monitor
An observational study of Heart Failure and Heart Failure - NYHA II - IV, run by University Health Network, Toronto at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure - NYHA II - IV, Heart Failure Patients
- How many people
- 360 participants
- Where
- 3 sitesCanada
- Study dates
- 16 Jun 2026to Sep 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ben Kim, PhD contact
Canada3 sites, 3 recruiting
- Not yet recruiting
Southlake Health
Newmarket, Ontario, L3Y 2P9
Grace Bent, +1 905-895-4521 ext. 5155, clinicaltrials@southlake.ca
Christine Thew, +1 905-895-4521 ext. 5155, clinicaltrials@southlake.ca
- Recruiting
200 Elizabeth Street
Toronto, Ontario, M5G 2C4
Ryan Li, MASc, +16479669330, ryan.li@uhn.ca
Ben Kim, PhD, ben.kim@uhn.ca
- Not yet recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario
Mahsa Sadeghi, Mahsa.Sadeghi@Sunnybrook.ca
Fernanda Calle, 416-480-4822, fernanda.calle@sunnybrook.ca
About this study
Official title: 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.
Read the 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:
- 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?
- 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:
- 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?
- 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?
- 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?
- Conditions
- Heart Failure, Heart Failure - NYHA II - IV, Heart Failure Patients, Cardiopulmonary Exercise Test, Apple Watch
- Keywords
- Apple Watch, CPET, Heart Failure, Artificial Intelligence, Wearable Technology, Wearable, Remote monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Cardiopulmonary Exercise Test Parameters
Measure the predictive power of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data against reductions in measured cardiorespiratory fitness, using K5 device in heart failure patients
Measured: 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 from clinical visits, bloodwork, and medication changes.
Measured: 7 months
Secondary outcomes (3)
Prediction of Cardiopulmonary Exercise Test Parameters
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 Cardiopulmonary Exercise Test using a K5 device.
Measured: 7 months
Prediction of worsening Heart Failure as a combined and stratified outcome
Measure predictive power of biometric data obtained from Apple Watch in combination with clinical and/or demographical data against worsening heart failure
Measured: 2 years
Prediction of existing markers of poor prognosis
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 as measured by K5 device
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start16 Jun 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Heather Ross, University Health Network, Toronto
- Investigators
- Heather Ross, MD, Study chair, University Health Network, TorontoChris McIntosh, PhD, Principal investigator, University Health Network, TorontoYasbanoo Moayedi, MD, Principal investigator, University Health Network - Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447908
- Sponsor's protocol ID
- 25-5233
- Other IDs
- 203992
- Acronym
- TRUE-HF 2
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ted Rogers Understanding of Exacerbations in Heart Failure 2 (TRUE-HF2): Observational Study
- ClinicalTrials.gov ID
- NCT07447908
- Acronym / sponsor ID
- TRUE-HF 2 / 25-5233
- Conditions
- Heart Failure, Heart Failure - NYHA II - IV, Heart Failure Patients, Cardiopulmonary Exercise Test, Apple Watch
- Keywords
- Apple Watch, CPET, Heart Failure, Artificial Intelligence, Wearable Technology, Wearable, Remote monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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?
- 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:
- 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?
- 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?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of Cardiopulmonary Exercise Test Parameters
Time frame: 7 months
Measure the predictive power of cardiorespiratory fitness estimated from data obtained from Apple Watch in combination with clinical and/or demographical data against reductions in measured cardiorespiratory fitness, using K5 device in heart failure patients
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 from clinical visits, bloodwork, and medication changes.
3 secondary outcomes
Prediction of Cardiopulmonary Exercise Test Parameters
Time frame: 7 months
Prediction of worsening Heart Failure as a combined and stratified outcome
Time frame: 2 years
Prediction of existing markers of poor prognosis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben Kim, PhD contact
Heather Ross, MD study chair
University Health Network, Toronto
Chris McIntosh, PhD principal investigator
University Health Network, Toronto
Yasbanoo Moayedi, MD principal investigator
University Health Network - Toronto General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure - NYHA II - IV, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Li, MASc (6479669330, ryan.li@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Cardiopulmonary Exercise Test Parameters (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.