ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612001178831

Ethics application status

Approved

Date submitted

30/10/2012

Date registered

6/11/2012

Date last updated

11/09/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Diabetic cardiomyopathy: predictors of progression and outcome after 10 years of follow up.

Scientific title

Diabetic cardiomyopathy: predictors of progression and outcome after 10 years of follow up. A ten year follow up of participants in an earlier original research study by the same group which studied a large cohort of type II diabetes patients, looking for early identification of cardiomyopathy.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1136-5107

Trial acronym

Linked study record

Health condition

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

Diabetic cardiomyopathy

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

10 year follow up to assess development of cardiomyopathy in diabetic patients. Participation involves:
*Measurement of height, weight, waist circumference and blood pressure
Fasting blood test
* Cardiac echocardiograph test, including a carotid artery ultrasound scan
*An exercise stress test (if participants are able to exercise)
*Participants will also be asked to provide a list to the study staff of all medications, including the length of time each medication has been taken.
The testing will be arranged to take place in one 2 hour session.

Intervention code [1]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of major cardiac adverse events (MACE), and complications related to T2DM - as assessed by data linkage to medical records.

Timepoint [1]

From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012

Primary outcome [2]

That ACE inhibitor/ARB therapy and/or beta-blocker therapy will prevent progression of diabetic cardiomyopathy.
The use of these medications by participants will be noted over the 10 year period and compared with participant echocardiographic and exercise stress test measurements which assess the degree of cardiomyopathy, major adverse cardiac events and mortality.

Timepoint [2]

From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012

Primary outcome [3]

To establish that 2D speckle tracking strain (2DS) is superior to current echocardiographic techniques for the detection of DCM and better able to assess risk in diabetic cardiomyopathy over long term follow up.

Timepoint [3]

From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Participation will be invited from all surviving participants of the original study commenced in 2003.
Inclusion criteria:
-Age >18 years, and <85 years
-Diagnosed with type 2 diabetes
-Appropriate informed consent obtained and signed

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-Patients unwilling to comply with frequent follow-up
-Patients currently enrolled in another investigational study
-Patients whose life expectancy is severely limited due to pre-existing malignancy or other disease (< 6 months)
-Pregnancy

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

29/01/2013

Actual

15/08/2013

Date of last participant enrolment

Anticipated

20/08/2014

Actual

20/08/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland, Cardiovascular Imaging Research Centre, School of Medicine

Address [1]

Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Tony Stanton

Address

School of Medicine, University of Queensland
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Brian Haluska

Address [1]

School of Medicine, University of Queensland
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Prof Thomas Marwick

Address [1]

Menzies Institute
Medical Science 1

17 Liverpool Street

Hobart TAS 7000

Australia

Postal Address:
Private Bag 23

Hobart TAS 7000

Australia

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Prof John Prins

Address [2]

Mater Medical Research Unit
Mater Hospital
550 Stanley Street
SOUTH BRISBANE QLD 4101

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Hospital and Health Service HREC

Ethics committee address [1]

Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/09/2012

Ethics approval number [1]

HREC/12/QPAH/353

Summary

Brief summary

Type 2 diabetes mellitus (T2DM) is the fastest growing chronic disease in Australia today with an estimated 275 new cases every day. Currently 1.7 million Australians have diabetes and it is thought that up to half of these individuals are as yet undiagnosed. The annual cost of diabetes to the Australian healthcare system is estimated at least $3 billion. Diabetes was the underlying cause for 3.0% deaths registered in Australia in 2009 and additionally contributed to 10.1% deaths as either an underlying or associated cause of death. Worldwide it is anticipated that by the year 2025 there will be 300 million people with the disease especially given the epidemic of obesity and impact of sedentary lifestyles. 
It is known that individuals with diabetes have a significantly increased risk of cardiovascular disease. Recent data showed that this condition is underappreciated with 48% of all diabetic individuals, who had no previous history of structural heart disease, having evidence of Diabetic Cardiomyopathy echocardiographically. In diabetics, a complex series of metabolic disturbances results in heart fibrosis and enlargement.  which ultimately leads to clinical heart failure. 
Despite 4 decades of research there are currently no specific treatments for diabetic cardiomyopathy. Prevention of this condition requires its early identification and treatment.  Early treatment with medications known to improve heart failure outcome such as angiotensin-converting enzyme inhibitors (ACEI) and beta-blockers has been suggested from meta-analysis data specifically looking at diabetic subjects in the major heart failure trials to be beneficial . There is yet to be a long term follow-up study to definitively confirm this. 
Much of the previous work focusing on the early identification of this condition has been carried out by the Cardiovascular Imaging Research group through involvement in an NHMRC Centre of Clinical Research Excellence Award (455832). Work initiated in 2003 studied a large cohort of T2DM patients in a randomized controlled trial of lifestyle intervention. The results of this research were groundbreaking, proving that diabetic cardiomyopathy was able to be identified using novel echocardiographic imaging techniques. The proposed project aims to provide long term (10 year) follow up data on these original participants. To our knowledge this will be unique data within the literature allowing identification of markers of long term adverse prognosis and information about the factors affecting the progression of diabetic cardiomyopathy over time. 

Hypotheses 
The following hypotheses will be tested: 
1. Diabetic cardiomyopathy is prevalent and progressive over time. Clinical and widely available testing including echocardiography and cardiopulmonary exercise testing is able to identify long term risk markers for diabetic cardiomyopathy which result in adverse cardiovascular morbidity and mortality. 

2. Novel echocardiographic techniques,  are superior to current echocardiographic techniques for the detection of diabetic cardiomyopathy and are better able to assess cardiac risk as evidenced by subclinical left ventricular dysfunction. 

3. ACE inhibitor/Angiotensin Receptor Blocker (ARB) therapy and/or beta-blocker therapy will prevent the progression of DCM over long term follow-up.

Trial website

Trial related presentations / publications

Original RCT trial was not registered in 2003.  Publications resulting from the earlier trial are as follows:
Fang ZY, Schull-Meade R, Downey M, Prins J, Marwick TH. Determinants of subclinical diabetic heart disease. Diabetologia 2005; 48: 394–402. 
. Fang ZY, Sharman J, Prins JB, Marwick TH. Determinants of exercise capacity in patients with type 2 diabetes. Diabetes Care. 2005; 28(7): 1643-8. 
Hordern MD, Coombes JS, Cooney LM, Jeffriess L, Prins JB, Marwick TH. Effects of exercise intervention on myocardial function in type 2 diabetes. Heart 2009; 95(16): 1343-9. 
Hare JL, Hordern MD, Leano R, Stanton T, Prins JB, Marwick TH. Application of an exercise intervention on the evolution of diastolic dysfunction in patients with diabetes mellitus: efficacy and effectiveness. Circ Heart Fail. 2011; 4(4): 441-9.

Public notes

Contacts

Principal investigator

Name

A/Prof Tony Stanton

Address

Cardiovascular Imaging Research Centre
University of Queensland School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

+61 7 3176 5813

Fax

+61 7 3176 5399

t.stanton@uq.edu.au

Contact person for public queries

Name

Julie Holliday

Address

School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

+61731766146

Fax

+61731765399

j.holliday@uq.edu.au

Contact person for scientific queries

Name

A/Prof Tony Stanton

Address

School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102

Country

Australia

Phone

+61731765813

Fax

+61731765399

t.stanton@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

Source	Title	Year of Publication	DOI
Embase	Subclinical LV dysfunction and 10-year outcomes in type 2 diabetes mellitus.	2015	https://dx.doi.org/10.1136/heartjnl-2014-307391

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

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Documents added manually

Documents added automatically