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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Enza De Luca, RN contact

416-340-4800

enza.deluca@uhn.ca

Ben Kim, PhD contact

416-340-4800

ben.kim@uhn.ca

Canada1 site, 1 recruiting
  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

    Enza De Luca, RN, 416-340-4800, enza.deluca@uhn.ca

    Recruiting

Other trials in Canada

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:

  1. Can biometric data obtained from the Apple Watch be used to estimate cardiorespiratory fitness, as assessed by CPET?
  2. Does the 'predicted' Apple 6 MW estimate correlate with formal 6 MWT? Secondary Research Questions:
  3. 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?
  4. 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?
  5. 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?
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.

  1. 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

  2. 6 minute walk test

    Correlation of Apple 6MW estimate with measured 6MWT

    Measured: 3 months

Secondary outcomes (3)
  1. 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

  2. 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

  3. 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.

  1. First posted17 Aug 2021
  2. Study start1 Dec 2020
  3. Primary completionJul 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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)
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

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; AzTrials last refreshed its copy on 7 Nov 2026.

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