Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000818437
Ethics application status
Approved
Date submitted
8/07/2025
Date registered
31/07/2025
Date last updated
31/07/2025
Date data sharing statement initially provided
31/07/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using cardiac magnetic resonance imaging (MRI) to measure left ventricular wall stress in patients with asymptomatic aortic stenosis
Scientific title
Accuracy of using cardiac magnetic resonance imaging (MRI) to measure left ventricular wall stress and predict clinical outcomes in patients with asymptomatic aortic stenosis
Secondary ID [1] 314845 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Valvular heart disease 338113 0
Aortic stenosis 338114 0
Condition category
Condition code
Cardiovascular 334408 334408 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cardiac magnetic resonance imaging (Cardiac MRI)
- Duration of scan 30-45mins
- One scan at the commencement of the study
- Gadolinium intravenous contrast injection during the MRI (approximately 0.2 mL/kg)
- Scan administered by an RMH radiographer
- Scan reported by MRI radiologist & cardiologist
Intervention code [1] 331449 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342100 0
Composite - death, stroke, cardiovascular hospitalisation, aortic valve intervention
Timepoint [1] 342100 0
12-months and 24- months post cardiac MRI
Secondary outcome [1] 449577 0
Myocardial infarction
Timepoint [1] 449577 0
12-months and 24-months post cardiac MRI
Secondary outcome [2] 450133 0
Adverse cardiac remodelling (composite endpoint of imaging endpoints: left ventricular (LV) hypertrophy, LV mass, systolic LV wall stress, diastolic function (left atrial (LA) volume, mitral valve E/A, E/E’, tricuspid systolic jet velocity), traditional parameters of AS severity (aortic valve (AV) mean pressure gradient, aortic valve area, dimensionless index), T1 pre and post contrast, late gadolinium enhancement)
Timepoint [2] 450133 0
At time of cardiac MRI, 24 month repeat TTE
Secondary outcome [3] 450134 0
Composite - symptom status and quality of life
Timepoint [3] 450134 0
At recruitment, 12 months and 24 months post cardiac MRI
Secondary outcome [4] 450135 0
Six minute walk test
Timepoint [4] 450135 0
At recruitment, 12 months and 24 months post cardiac MRI

Eligibility
Key inclusion criteria
Adult patients with asymptomatic aortic stenosis (AS) (moderate or severe) determined on transthoracic echocardiography (TTE) as either:

- Moderate:
o Aortic valve area (AVA) 20mmHg

- Severe:
o AVA 40mmHg
o Dimensionless index (DI) <0.25
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any contraindication to cardiac MRI, including suspected metallic foreign bodies (patients will not be screened with X-rays.
• Any contraindication to gadolinium contrast.
• Claustrophobia.
• estimated glomellular filtration rate (eGFR) <30.
• Current pregnancy.
• Any cardiac implantable electronic device (CIED).
• History of transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).
• Severe left ventricular systolic dysfunction (left ventricular ejection fracton (LVEF) <35%).
• Severe airways disease.
• Unable to provide informed consent

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2025
Date of last participant enrolment
Anticipated
4/01/2027
Actual
Date of last data collection
Anticipated
4/01/2029
Actual
Sample size
Target
100
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319406 0
Government body
Name [1] 319406 0
National Health and Medical Research Council
Country [1] 319406 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 321891 0
None
Name [1] 321891 0
Address [1] 321891 0
Country [1] 321891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317977 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 317977 0
Ethics committee country [1] 317977 0
Australia
Date submitted for ethics approval [1] 317977 0
18/02/2025
Approval date [1] 317977 0
03/03/2025
Ethics approval number [1] 317977 0

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

Contacts
Principal investigator
Name 142754 0
Prof Andrew Taylor
Address 142754 0
Department of Cardiology, Royal Melbourne Hospital, Level 2, 300 Grattan Street Parkville VIC 3050
Country 142754 0
Australia
Phone 142754 0
+61393427133
Fax 142754 0
Email 142754 0
[email protected]
Contact person for public queries
Name 142755 0
Andrew Taylor
Address 142755 0
Department of Cardiology, Royal Melbourne Hospital, Level 2, 300 Grattan Street Parkville VIC 3050
Country 142755 0
Australia
Phone 142755 0
+61393427133
Fax 142755 0
Email 142755 0
[email protected]
Contact person for scientific queries
Name 142756 0
Andrew Taylor
Address 142756 0
Department of Cardiology, Royal Melbourne Hospital, Level 2, 300 Grattan Street Parkville VIC 3050
Country 142756 0
Australia
Phone 142756 0
+61393427133
Fax 142756 0
Email 142756 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.