Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000080628
Ethics application status
Approved
Date submitted
5/01/2014
Date registered
22/01/2014
Date last updated
22/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
TAsmanian Study of Echocardiographic detection of Left ventricular dysfunction (TAS-ELF)
Scientific title
Study of heart failure outcomes in stage A heart failure patients screened using advanced echocardiography techniques.
Secondary ID [1] 283847 0
None
Universal Trial Number (UTN)
Trial acronym
TAS-ELF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 290822 0
Condition category
Condition code
Cardiovascular 291190 291190 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inclusion of myocardial mechanics in screening echocardiography for heart failure. This screening test is envisaged at one point in time and the acquisition takes ~30 minutes.
Intervention code [1] 288527 0
Early detection / Screening
Comparator / control treatment
Performance of standard echocardiogram, an ultrasound test of the heart where ejection fraction (EF) is measured. This is an insensitive test for early changes sought be the intervention test, but is used to endure that patients with unrecognized established heart failure are managed safely. This screening test is envisaged at one point in time and the acquisition takes ~30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 291178 0
New heart failure (HF) or LV dysfunction. This will be assessed on the basis of clinical diagnosis of HF. LV dysfunctiuon will be defined on the basis of 3D echo.
Timepoint [1] 291178 0
24 months after the initial screening study
Secondary outcome [1] 306192 0
Cardiovascular fitness, assessed using 6-minute walk test
Timepoint [1] 306192 0
24 months after the initial screening study

Eligibility
Key inclusion criteria
Aged >65 years with one or more of the following;
- diabetes (T2DM)
- obesity
- high blood pressure
- past cancer chemotherapy
- F/H of heart failure
- known cardiac disease (but not existing heart failure)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide written informed consent to participate in this study
- Participating in another clinical research trial where randomized treatment would be unacceptable
- History of >moderate valvular heart disease
- History of previous heart failure
- Existing medical therapy with beta blockers and ACE inhibitors
- Contraindications/Intolerance to beta blockers or ACE inhibitors
- Systolic BP <110mmHg
- Pulse <60/minute
- Baseline NYHA >2
- Oncologic life expectancy < 12 months
- Inability to acquire interpretable images (identified from baseline echo)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At risk subjects will be self-referred (recruited directly by advertising in the community) and identified by general practitioners. We plan to compare 400 subjects with HF screening and therapy vs 400 controls.

Clinical evaluation: All subjects will undertake a clinical history and answer questionnaires on general health status (EQ5D), activity (DASI) and heart failure symptoms (MLHFQ). All will undergo a screening echo for overt LV dysfunction (EF <40%) or valvular disease. If these results are abnormal, subjects will be excluded.

Study protocol: A central (web-based) randomization program will be used to allocate patients to advanced vs conventional imaging only after the patient is enrolled. This allocation concealment will prevent the person performing recruitment from knowing the allocated group at the time of inclusion. Subsequent management decisions are not based on randomization and will occur as a "usual care' response to data provided from imaging.

Conventional imaging: Limited to evaluation of EF and valve disease.

Advanced cardiac imaging: Inclusion of global longitudinal strain and diastolic dysfunction evaluation. Presence of a global strain <16% or raised filling pressure at diastolic function evaluation will provoke GP referral for initiation of treatment (see below).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation). Randomization is stratified on the basis of diabetes status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Those with an abnormal test will be identified as having Stage B heart failure, and sent to their GP for treatment targeted at better blood pressure and glucose control. Additional protective therapy (ACE inhibitors and beta blockers) will be added and titrated to target dose by the GP.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcomes of patients will be compared with a t-test (change in 6-minute walk test) or survival analysis (heart failure). Multivariable models (respectively linear and Cox regression) will be developed to identify effect size, and will be extremely important if groups are mismatched despite randomization. All analyses will be performed on an intention to treat basis.

Power calculations - Assuming subclinical cardiac dysfunction in 30%, we would expect 120 patients suitable for treatment (which we would expect to reduce heart failure to 5%) and 280 to screen negative, in whom heart failure would be expected in 10%.
Assuming a similar 6-minute walk to previous work in patients with a similar risk profile to be 525+/-113m, so a 5% change could be identified with 297 patients per group at a power of 80%, at a p<0.05. Both calculations were performed using SPSS Sample Power 2.0, using respectively survival and t-test modules.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/09/2013
Date of last participant enrolment
Anticipated
30/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 7667 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 288499 0
Charities/Societies/Foundations
Name [1] 288499 0
Tasmanian Community Fund
Country [1] 288499 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute Tasmania
Address
17 Liverpool St
Hobart Tasmania 7000
Country
Australia
Secondary sponsor category [1] 287204 0
None
Name [1] 287204 0
Address [1] 287204 0
Country [1] 287204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290357 0
Health and Medical Human Research Ethics Committee
Ethics committee address [1] 290357 0
University of Tasmania
Private Bag 01 Hobart Tas 7001
Ethics committee country [1] 290357 0
Australia
Date submitted for ethics approval [1] 290357 0
Approval date [1] 290357 0
15/09/2013
Ethics approval number [1] 290357 0
H0013333

Summary
Brief summary
The aim of this project is to reduce the deaths caused by Heart Failure in Tasmania. This will be achieved through implementation of a screening program for cardiac dysfunction and the use of protective therapy that will limit the development of heart failure. We plan to show the benefit of testing by recruitment of "at risk" subjects from the community and randomising them to a screening program based on echocardiography. Patients with abnormalities will be entered into a program of cardio-protective therapy, supervised by their general practitioner.
Endpoints: 6-minute walk at a minimum of 24 months and comparison of the rate of heart failure among groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45306 0
Prof Thomas H Marwick
Address 45306 0
Menzies Research Institute Tasmania
17 Liverpool St
Hobart, Tas 7000
Country 45306 0
Australia
Phone 45306 0
+61 (0)3 6226 7703
Fax 45306 0
Email 45306 0
tom.marwick@utas.edu.au
Contact person for public queries
Name 45307 0
Ms Hilda Yang
Address 45307 0
Menzies Research Institute Tasmania
17 Liverpool St
Hobart, Tas 7000
Country 45307 0
Australia
Phone 45307 0
+61 (0)415 851 340
Fax 45307 0
Email 45307 0
hong.yang@utas.edu.au
Contact person for scientific queries
Name 45308 0
Prof Thomas H Marwick
Address 45308 0
Menzies Research Institute Tasmania
17 Liverpool St
Hobart, Tas 7000
Country 45308 0
Australia
Phone 45308 0
+61 (0)3 6226 7703
Fax 45308 0
Email 45308 0
tom.marwick@utas.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
SourceTitleYear of PublicationDOI
EmbaseImportance of Calibration Method in Central Blood Pressure for Cardiac Structural Abnormalities.2016https://dx.doi.org/10.1093/ajh/hpw039
EmbaseImaging-Guided Cardioprotective Treatment in a Community Elderly Population of Stage B Heart Failure.2017https://dx.doi.org/10.1016/j.jcmg.2016.11.015
EmbaseAssociation between socioeconomic status and incident atrial fibrillation.2019https://dx.doi.org/10.1111/imj.14214
EmbaseAssociation of Reduced Apical Untwisting With Incident HF in Asymptomatic Patients With HF Risk Factors.2020https://dx.doi.org/10.1016/j.jcmg.2019.01.035
EmbaseThe importance of calibration method in determining the association between central blood pressure with left ventricular and left atrial strain.2022https://dx.doi.org/10.1007/s10554-021-02444-4
N.B. These documents automatically identified may not have been verified by the study sponsor.