Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000026527
Ethics application status
Approved
Date submitted
17/01/2006
Date registered
20/01/2006
Date last updated
20/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of latent left ventricular dysfunction in asymptomatic severe valvular regurgitation
Scientific title
Assessment of latent left ventricular dysfunction in asymptomatic severe valvular regurgitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral regurgitation 987 0
Condition category
Condition code
Cardiovascular 1063 1063 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Mitral valve surgery
Intervention code [1] 842 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1424 0
Predict latent LV dysfunction (loss of contractile reserve with isotonic exercise) with myocardial strain and cyclic variation of integrated backscatter (IB)
Timepoint [1] 1424 0
Secondary outcome [1] 2517 0
Correlate strain and IB with the presence and severity of myocardial fibrosis, assessed with fine needle biopsy.
Timepoint [1] 2517 0
Secondary outcome [2] 2518 0
Predict clinical outcome (preservation of LV function, exercise capacity and quality of life) with strain and IB.
Timepoint [2] 2518 0

Eligibility
Key inclusion criteria
Severe asymptomatic/minimally symptomatic MR.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known coronary artery disease, previous cardiac surgery, greater than mild mitral stenosis and significant aortic valve disease (stenosis or regurgitation) and suboptimal images.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1163 0
Charities/Societies/Foundations
Name [1] 1163 0
National Heart Foundation
Country [1] 1163 0
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation
Address
Country
New Zealand
Secondary sponsor category [1] 1024 0
None
Name [1] 1024 0
none
Address [1] 1024 0
Country [1] 1024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2480 0
Princess Alexandra Hospital
Ethics committee address [1] 2480 0
Ethics committee country [1] 2480 0
Australia
Date submitted for ethics approval [1] 2480 0
Approval date [1] 2480 0
Ethics approval number [1] 2480 0

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

Contacts
Principal investigator
Name 36038 0
Address 36038 0
Country 36038 0
Phone 36038 0
Fax 36038 0
Email 36038 0
Contact person for public queries
Name 10031 0
Professor T Marwick
Address 10031 0
Department of Medicine
University of Queensland
Princess Alexandra Hospital
Brisbane QLD 4102
Country 10031 0
Australia
Phone 10031 0
+61 7 32405345
Fax 10031 0
Email 10031 0
tmarwick@soms.uq.edu.au
Contact person for scientific queries
Name 959 0
Dr S Wahi
Address 959 0
Department of Cardiology
Princess Alexandra Hospital
Brisbane QLD 4102
Country 959 0
Australia
Phone 959 0
+61 7 32402111
Fax 959 0
Email 959 0
swahi@soms.uq.edu.au

No information has been provided regarding IPD availability


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.