Heart FailureTRUE-HFNCT05008692
Apple-CPET Ted Rogers Understanding Exacerbations of Heart Failure
An observational study of Heart Failure and Heart Failure, Systolic, run by University Health Network, Toronto at 1 site 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, Systolic, Heart Failure, Diastolic
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 (>17 years of age), ambulatory heart failure patients currently followed by the University Health Network.
Who may be able to join
- 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
Who cannot join
- Physical disability that prevents exercise testing
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Enza De Luca, RN, 416-340-4800, enza.deluca@uhn.ca
About this study
Official title: Measuring Cardiopulmonary Fitness in Ambulatory Heart Failure Patients Through the Use of Apple Watch Features
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
Read the detailed description
Heart Failure (HF) has a prevalence of 3.5% suggesting that over one million Canadians are affected by this disease, and more than 50,000 are newly diagnosed each year. This complex disease is associated with the highest burden of cost to the healthcare system, attributable to hospitalizations, missed work, medications, and health care services
Traditionally, clinicians have relied on static snapshots of patients to determine clinical status and estimate prognosis. More advanced cardiac centers rely on cardiopulmonary exercise testing (CPET), where patients are further stratified based on validated exercise parameters. CPET remains underutilized and resource-intensive. It requires expensive equipment, proficient personnel, and clinicians with specialized training. Thus, there is an unmet need for a more widely available, accessible, and longitudinal assessment of clinical status to better monitor and prognosticate patients outside of the ambulatory setting. Wearable devices such as the Apple Watch hold great promise in this regard, as they provide near-continuous monitoring of biometric data. By combining biometric data with demographic, cardiac, and biomarker testing, the investigators will significantly improve our ability to predict heart failure outcomes such as early warning of decompensation, clinical deterioration (symptoms and brain natriuretic peptide (BNP) as a surrogate), hospitalization, mortality (using the Seattle Heart Failure Model (SHFM) as a surrogate), and/or need for advanced heart failure therapies.
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 Question:
- Can biometric data obtained from the Apple Watch be used to estimate cardiorespiratory fitness, as assessed by CPET?
- Does the 'predicted' Apple 6 MW estimate correlate with formal 6 MWT? Secondary Research Questions:
- Is there a relationship between novel biosensors, including oxygen saturation, and markers of poor prognosis specifically as defined by the SHFM, BNP, Quality of life (QOL) indicators, and CPET parameters?
- Can surrogates of cardiorespiratory fitness obtained from the Apple Watch, including novel biosensors, predict acute decompensation of heart failure as defined rapid clinic visits, need for IV diuretics, ED visits, heart failure hospitalization and unscheduled health care encounters during the 3-month follow-up?
- Can biometric data be used to improve a risk prediction model that can distinguish between patients at high versus low risk of all-cause hospitalization (primary outcome), all-cause mortality (secondary outcome), and a composite outcome of all-cause mortality, need for ventricular assist device, or heart transplantation (secondary composite outcome) over a 2 year period?
- Conditions
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Transplantation, Heart Failure,Congestive
- Keywords
- Wearable, Apple Watch, Cardiopulmonary Exercise Test, 6MWT, Biomarker, peak VO2, Patient Reported Outcomes, QOL
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Apple Watch metrics prediction of CPET parameters
Measure predictive power of Apple Watch metrics such as heart rate against CPET parameters such as peak VO2
Measured: 3 months
6 minute walk test
Correlation of Apple 6MW estimate with measured 6MWT
Measured: 3 months
Secondary outcomes (3)
Apple Watch sensors and markers of poor prognosis
Correlation between novel biosensors, including oxygen saturation, and markers of poor prognosis specifically as defined by the Seattle Heart Failure Model (SHFM), BNP, Quality of life (QOL) and CPET parameters
Measured: 3 months
Apple Watch Sensors and unscheduled visits
Identify whether Apple Watch sensors including estimated peak VO2 predict a composite outcome of unscheduled visits (including: rapid clinic visits, need for IV diuretics, ED visit and HF hospitalization)
Measured: 3 months
Biomarkers and digital signatures as a predictor of composite rehospitalisation, advanced therapies and mortality
Identify novel biomarkers (eg. ST2, cell-free DNA, peripheral markers of the microbiome) collected by the biobank and digital signatures assessed by the Apple Watch (eg. behaviors, exercise, medication adherence) that predict a composite outcome of mortality, advanced heart failure therapies and hospitalizations
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 posted17 Aug 2021
- Study start1 Dec 2020
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc.
- Responsible party
- Principal investigator, Heather Ross, University Health Network, Toronto
- Investigators
- Heather J Ross, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008692
- Sponsor's protocol ID
- 20-5205
- Acronym
- TRUE-HF
- Status last verified
- Nov 2022
- First submitted
- 24 Jul 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moayedi Y, Foroutan F, Gao Y, Kim B, De Luca E, Brum M, Brahmbhatt DH, Duhamel J, Simard A, McIntosh C, Ross HJ. Developments in Digital Wearable in Heart Failure and the Rationale for the Design of TRUE-HF (Ted Rogers Understanding of Exacerbations in Heart Failure) Apple CPET Study. Circ Heart Fail. 2025 Jun;18(6):e012204. doi: 10.1161/CIRCHEARTFAILURE.124.012204. Epub 2025 May 9.
PubMed 40340421
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Cardiopulmonary Fitness in Ambulatory Heart Failure Patients Through the Use of Apple Watch Features
- ClinicalTrials.gov ID
- NCT05008692
- Acronym / sponsor ID
- TRUE-HF / 20-5205
- Conditions
- Heart Failure, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Transplantation, Heart Failure,Congestive
- Keywords
- Wearable, Apple Watch, Cardiopulmonary Exercise Test, 6MWT, Biomarker, peak VO2, Patient Reported Outcomes, QOL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Apple Inc.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Aug 2021 (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 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
Detailed description
Heart Failure (HF) has a prevalence of 3.5% suggesting that over one million Canadians are affected by this disease, and more than 50,000 are newly diagnosed each year. This complex disease is associated with the highest burden of cost to the healthcare system, attributable to hospitalizations, missed work, medications, and health care services
Traditionally, clinicians have relied on static snapshots of patients to determine clinical status and estimate prognosis. More advanced cardiac centers rely on cardiopulmonary exercise testing (CPET), where patients are further stratified based on validated exercise parameters. CPET remains underutilized and resource-intensive. It requires expensive equipment, proficient personnel, and clinicians with specialized training. Thus, there is an unmet need for a more widely available, accessible, and longitudinal assessment of clinical status to better monitor and prognosticate patients outside of the ambulatory setting. Wearable devices such as the Apple Watch hold great promise in this regard, as they provide near-continuous monitoring of biometric data. By combining biometric data with demographic, cardiac, and biomarker testing, the investigators will significantly improve our ability to predict heart failure outcomes such as early warning of decompensation, clinical deterioration (symptoms and brain natriuretic peptide (BNP) as a surrogate), hospitalization, mortality (using the Seattle Heart Failure Model (SHFM) as a surrogate), and/or need for advanced heart failure therapies.
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 Question:
- Can biometric data obtained from the Apple Watch be used to estimate cardiorespiratory fitness, as assessed by CPET?
- Does the 'predicted' Apple 6 MW estimate correlate with formal 6 MWT? Secondary Research Questions:
- Is there a relationship between novel biosensors, including oxygen saturation, and markers of poor prognosis specifically as defined by the SHFM, BNP, Quality of life (QOL) indicators, and CPET parameters?
- Can surrogates of cardiorespiratory fitness obtained from the Apple Watch, including novel biosensors, predict acute decompensation of heart failure as defined rapid clinic visits, need for IV diuretics, ED visits, heart failure hospitalization and unscheduled health care encounters during the 3-month follow-up?
- Can biometric data be used to improve a risk prediction model that can distinguish between patients at high versus low risk of all-cause hospitalization (primary outcome), all-cause mortality (secondary outcome), and a composite outcome of all-cause mortality, need for ventricular assist device, or heart transplantation (secondary composite outcome) over a 2 year period?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>17 years of age), ambulatory heart failure patients currently followed by the University Health Network.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Physical disability that prevents exercise testing
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
Apple Watch metrics prediction of CPET parameters
Time frame: 3 months
Measure predictive power of Apple Watch metrics such as heart rate against CPET parameters such as peak VO2
6 minute walk test
Time frame: 3 months
Correlation of Apple 6MW estimate with measured 6MWT
3 secondary outcomes
Apple Watch sensors and markers of poor prognosis
Time frame: 3 months
Apple Watch Sensors and unscheduled visits
Time frame: 3 months
Biomarkers and digital signatures as a predictor of composite rehospitalisation, advanced therapies and mortality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 40340421Moayedi Y, Foroutan F, Gao Y, Kim B, De Luca E, Brum M, Brahmbhatt DH, Duhamel J, Simard A, McIntosh C, Ross HJ. Developments in Digital Wearable in Heart Failure and the Rationale for the Design of TRUE-HF (Ted Rogers Understanding of Exacerbations in Heart Failure) Apple CPET Study. Circ Heart Fail. 2025 Jun;18(6):e012204. doi: 10.1161/CIRCHEARTFAILURE.124.012204. Epub 2025 May 9.
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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. This study is not recruiting at the moment.
Heather J Ross, MD principal investigator
University Health Network, Toronto
1 site 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, Systolic, run by University Health Network, Toronto at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enza De Luca, RN (416-340-4800, enza.deluca@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apple Watch metrics prediction of CPET parameters (time frame: 3 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?
On the ClinicalTrials.gov record for NCT05008692, which also lists 1 linked publication.
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 16 Nov 2022.