Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000768493
Ethics application status
Approved
Date submitted
5/05/2025
Date registered
21/07/2025
Date last updated
21/07/2025
Date data sharing statement initially provided
21/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Heart Watch Study - Self-testing for Heart Disease Using Smartwatch Electrocardiogram (ECG)
Scientific title
Prognostic performance of smartwatch 12-lead ECG with advanced ECG analysis in consumer self-screening of cardiovascular disease
Secondary ID [1] 314358 0
Nil Known
Universal Trial Number (UTN)
U1111-1322-2675
Trial acronym
HWS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 337350 0
Condition category
Condition code
Cardiovascular 333734 333734 0 0
Coronary heart disease
Cardiovascular 333735 333735 0 0
Other cardiovascular diseases
Cardiovascular 333741 333741 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is no exposure or intervention, this is an observational research. Participants will be recruited online. The study involves downloading an iPhone App that will allow recording a 12-lead ECG using an ECG enabled Apple Watch. Participants will use their own Apple Watches, access to one as an enrolment criterion. Apple Watches will not be supplied as part of this study.

The study iPhone App will guide the participants through the recording process from the comfort of their home. Ideally they should have had a period of 10 minutes rest. The total number of recordings required is 15 recordings, at 30 seconds each, totalling 7 minutes and 30 seconds. Add roughly 10-15 minutes of preparation, we anticipate the total recording time to take 15-20 minutes in total from our experience.

The resulting smartwatch ECG will be sent to the study servers for both conventional manual human analysis and Advanced ECG algorithmic analysis.

Manual analysis involves visual assessment of the ECG, and is the standard read out of the ECG by qualified ECG technicians as per current clinical standards.

Advanced ECG analysis uses advanced digital signal processing to derive a large number of ECG features, including vectorcardiography and wave complexity measures. These features are then combined in a multivariable machine learning model to generate scores for disease probabilities.

If a number of pre-defined abnormalities are found, participants are contacted via email with all the required information to share with their GP within 30 days of recording and submitting their smartwatch ECG.

Otherwise, their outcomes will be assessed via data linkage at 2 years from the date of enrolment. The primary outcomes for this particular study will be cardiovascular events at 2 years. The data linkage sources will be via the dedicated state research health data linkage such as the Centre for Health Record Linkage in NSW and ACT, and is counterparts in other states that record mortality and hospitalisation data. While the Heart Watch Study concludes after 2 years and the results published, data will remain stored indefinitely leaving the door open for further research down the track. This is clearly indicated in the HREC approved Participant Information Sheet.

The Heart Age is simply another measure of Advanced ECG analysis and does not involve any extra steps or procedures on behalf of the participant. It will be done only once during the initial analysis at enrolment.

The snapshot of daily activities are captured by the study A-ECG app from their Apple Health app with the user's permission. No extra interviews or steps are required on the participants' side.
Intervention code [1] 330973 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341326 0
Incidence of cardiovascular events (ie death or hospitalisation from cardiovascular causes) at 2 years'
Timepoint [1] 341326 0
2 years after recruitment.
Secondary outcome [1] 447117 0
To determine the prognostic value of A-ECG Heart Age from 12-lead Apple Watch ECG.
Timepoint [1] 447117 0
2 years after recruitment
Secondary outcome [2] 447120 0
The prevalence of smartwatch 12-lead ECG findings requiring a recommendation for further healthcare evaluation
Timepoint [2] 447120 0
Within 30 days of self-recorded ECG conducted and submitted through the study App using an Apple Watch

Eligibility
Key inclusion criteria
Electronically obtained informed consent
Individuals with access to Apple Watch series 4 or later and an iPhone and no prior known heart disease.

Minimum age
20 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of existing heart disease including arrhythmia, cardiomyopathy, ischemic heart disease, history of percutaneous coronary intervention or bypass surgery, congenital heart disease, valvular disease, bundle branch blocks and implanted cardiac devices.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Time-to-event analysis will be performed using Kaplan-Meier analysis with censoring at study end. The association of Apple Watch A-ECG scores with MACE will be assessed using Cox proportional hazards regression models, unadjusted and adjusted for confounders. Hazard ratios (HRs) will be presented with 95 % confidence intervals (CIs).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
2/08/2027
Actual
Date of last data collection
Anticipated
2/08/2027
Actual
Sample size
Target
30000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318878 0
Other Collaborative groups
Name [1] 318878 0
MTPConnect
Country [1] 318878 0
Australia
Funding source category [2] 319237 0
Government body
Name [2] 319237 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [2] 319237 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321345 0
None
Name [1] 321345 0
Address [1] 321345 0
Country [1] 321345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317492 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317492 0
Ethics committee country [1] 317492 0
Australia
Date submitted for ethics approval [1] 317492 0
29/06/2022
Approval date [1] 317492 0
27/09/2022
Ethics approval number [1] 317492 0
2022/ETH01269

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141226 0
Prof Martin Ugander
Address 141226 0
The Kolling Institute, 10 Westbourne St, St Leonards NSW 2064
Country 141226 0
Australia
Phone 141226 0
+61299264500
Fax 141226 0
Email 141226 0
[email protected]
Contact person for public queries
Name 141227 0
Dr Zaidon Al-Falahi
Address 141227 0
The Kolling Institute, 10 Westbourne St, St Leonards NSW 2064
Country 141227 0
Australia
Phone 141227 0
+61299264500
Fax 141227 0
Email 141227 0
[email protected]
Contact person for scientific queries
Name 141228 0
Prof Martin Ugander
Address 141228 0
The Kolling Institute, 10 Westbourne St, St Leonards NSW 2064
Country 141228 0
Australia
Phone 141228 0
+61 02 9926 4500
Fax 141228 0
Email 141228 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.