Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000793314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
9/06/2026
Date registered
Help: Date registered
2/07/2026
Date last updated
Help: Date last updated
2/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
2/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A two-step screening pathway to detect early heart failure in cancer survivors: the TRIAGE-HF pilot study
Scientific title
Diagnostic accuracy of a sequential screening pathway (CHERISH risk score and AI-enabled electrocardiography) for detecting stage B heart failure in cancer survivors: the TRIAGE-HF pilot study
Additional trial identifiers [1] 317534 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRIAGE-HF
Related trial records

Health condition
Health condition(s) studied:
Stage B heart failure 342277 0
Cancer 342278 0
Condition category
Condition code
Cardiovascular 338390 338390 0 0
Other cardiovascular diseases
Cancer 338391 338391 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All participants undergo a single study visit comprising a two-step sequential screening pathway followed by reference-standard echocardiography. No therapeutic intervention is administered; the screening outputs are investigational and are not used to guide clinical care during the study.

Step 1 — CHERISH risk score: A previously developed clinical risk score for heart failure in cancer survivors is calculated for every participant from self-reported categorical clinical items and basic demographics (no medical-record access required). Participants with a score greater than or equal to 3% are classified as high risk (screen positive at this step). The publicly available calculator is at https://baker-biostats.shinyapps.io/CHERISH/. The CHERISH risk score will be documented in the research database (REDCap).

Step 2 — AI-enabled electrocardiography (AI-ECG): All participants undergo a standard, resting 12-lead energy waveform ECG (ewECG) using the MyoVista device (version 2.0; HeartSciences, Southlake, Texas, USA) performed by research assistant. An integrated, non-adaptive (fixed-parameter) machine-learning algorithm automatically generates a probability score (0–1) for subclinical cardiac dysfunction, displayed alongside the ECG trace. A probability of greater than or equal to 0.61 is classified as screen positive. Acquisition requires no procedure beyond standard 12-lead ECG and will take no more than 15 minutes. The AI-ECG risk probability will be documented in the research database (REDCap).

Under the sequential framework, a participant is screen positive if either (1) CHERISH-defined high risk, or (2) AI-ECG-positive among those initially low risk.

Duration of observation: Cross-sectional: a single visit per participant with no follow-up. All assessments occur within that one visit.
Intervention code [1] 334328 0
Treatment: Devices
Intervention code [2] 334402 0
Early detection / Screening
Description of the comparator or control
All participants undergo standard heart ultrasound (also known as echocardiography) to assess if participants have any structural or functional abnormalities in their heart.

The echo images are interpreted by qualified sonographers or cardiologists blinded to the CHERISH and AI-ECG results.
Control group
Active

Outcomes
Primary outcome [1] 345703 0
Stage B heart failure
Timepoint [1] 345703 0
ECG and echocardiography will be performed on the same-day.
Secondary outcome [1] 462966 0
Diastolic dysfunction
Timepoint [1] 462966 0
ECG and echocardiography will be performed on the same-day.
Secondary outcome [2] 463284 0
Global longitudinal strain
Timepoint [2] 463284 0
ECG and echocardiography will be performed on the same-day.
Secondary outcome [3] 463285 0
Left ventricular hypertrophy
Timepoint [3] 463285 0
ECG and echocardiography will be performed on the same-day.

Eligibility
Key inclusion criteria
1. Adults aged greater than or equal to 40 years
2. Completed primary cancer therapy that is potentially cardiotoxic (chemotherapy, chest radiotherapy, or targeted therapy [e.g. trastuzumab])
3. Eligible for Medicare
4. Able to provide written informed consent
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Prior diagnosis of symptomatic heart failure
2. Moderate or severe valvular heart disease
3. Active cancer requiring ongoing treatment
4. Life expectancy less than 12 months due to concomitant disease
5. Inability to undergo ECG or echocardiographic assessment
6. Participation in another clinical research trial

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot prospective diagnostic validation study, the sample size was determined based on the precision of diagnostic accuracy estimates rather than hypothesis-testing power. The prevalence of SBHF among cancer survivors is assumed to be approximately 40%, based on previous work. Under this assumption, recruitment of 150 participants is expected to yield approximately 60 individuals with SBHF.

Using standard methods for estimating sensitivity and specificity in diagnostic studies, this sample size allows estimation of sensitivity and specificity with approximately ±10% precision around the point estimate, which is appropriate for early validation of a screening strategy.

The study is not powered for definitive subgroup performance estimates. The results will provide preliminary estimates of diagnostic performance and effect sizes to inform the design and sample size calculations of future larger multicentre validation studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322094 0
Government body
Name [1] 322094 0
NHMRC
Country [1] 322094 0
Australia
Funding source category [2] 322095 0
Government body
Name [2] 322095 0
NHMRC Investigator Grant
Country [2] 322095 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Baker Heart and Diabetes Institute
Address
Country
Australia
Secondary sponsor category [1] 324987 0
None
Name [1] 324987 0
Address [1] 324987 0
Country [1] 324987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320623 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 320623 0
Ethics committee country [1] 320623 0
Australia
Date submitted for ethics approval [1] 320623 0
11/05/2026
Approval date [1] 320623 0
02/06/2026
Ethics approval number [1] 320623 0
356/26

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

Contacts
Principal investigator
Name 151082 0
Dr Cheng Hwee Soh
Address 151082 0
Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC 3004
Country 151082 0
Australia
Phone 151082 0
+61 402 131 857
Fax 151082 0
Email 151082 0
[email protected]
Contact person for public queries
Name 151083 0
Cheng Hwee Soh
Address 151083 0
Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC 3004
Country 151083 0
Australia
Phone 151083 0
+61 402 131 857
Fax 151083 0
Email 151083 0
[email protected]
Contact person for scientific queries
Name 151084 0
Cheng Hwee Soh
Address 151084 0
Baker Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, VIC 3004
Country 151084 0
Australia
Phone 151084 0
+61 402 131 857
Fax 151084 0
Email 151084 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 10 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.