ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

None

Universal Trial Number (UTN)

Trial acronym

TAS-ELF

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Heart failure

Condition category

Condition code

Cardiovascular

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]

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]

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]

24 months after the initial screening study

Secondary outcome [1]

Cardiovascular fitness, assessed using 6-minute walk test

Timepoint [1]

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?

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]

7000 - Hobart

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Tasmanian Community Fund

Address [1]

GPO Box 1350
Hobart, Tasmania, 7001

Country [1]

Australia

Primary sponsor type

University

Name

Menzies Research Institute Tasmania

Address

17 Liverpool St
Hobart Tasmania 7000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Medical Human Research Ethics Committee

Ethics committee address [1]

University of Tasmania
Private Bag  01 Hobart Tas 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/09/2013

Ethics approval number [1]

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

Prof Thomas H Marwick

Address

Menzies Research Institute Tasmania
17 Liverpool St
Hobart, Tas 7000

Country

Australia

Phone

+61 (0)3 6226 7703

Fax

tom.marwick@utas.edu.au

Contact person for public queries

Name

Hilda Yang

Address

Menzies Research Institute Tasmania
17 Liverpool St
Hobart, Tas 7000

Country

Australia

Phone

+61 (0)415 851 340

Fax

hong.yang@utas.edu.au

Contact person for scientific queries

Name

Thomas H Marwick

Address

Menzies Research Institute Tasmania
17 Liverpool St
Hobart, Tas 7000

Country

Australia

Phone

+61 (0)3 6226 7703

Fax

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

Source	Title	Year of Publication	DOI
Embase	Importance of Calibration Method in Central Blood Pressure for Cardiac Structural Abnormalities.	2016	https://dx.doi.org/10.1093/ajh/hpw039
Embase	Imaging-Guided Cardioprotective Treatment in a Community Elderly Population of Stage B Heart Failure.	2017	https://dx.doi.org/10.1016/j.jcmg.2016.11.015
Embase	Association between socioeconomic status and incident atrial fibrillation.	2019	https://dx.doi.org/10.1111/imj.14214
Embase	Association of Reduced Apical Untwisting With Incident HF in Asymptomatic Patients With HF Risk Factors.	2020	https://dx.doi.org/10.1016/j.jcmg.2019.01.035
Embase	The importance of calibration method in determining the association between central blood pressure with left ventricular and left atrial strain.	2022	https://dx.doi.org/10.1007/s10554-021-02444-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically