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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] 281470 0
Nil
Universal Trial Number (UTN)
U1111-1136-5107
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic cardiomyopathy 287728 0
Condition category
Condition code
Cardiovascular 288066 288066 0 0
Coronary heart disease
Metabolic and Endocrine 288067 288067 0 0
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] 285973 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288275 0
Incidence of major cardiac adverse events (MACE), and complications related to T2DM - as assessed by data linkage to medical records.
Timepoint [1] 288275 0
From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012
Primary outcome [2] 288317 0
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] 288317 0
From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012
Primary outcome [3] 288318 0
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] 288318 0
From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012
Secondary outcome [1] 299838 0
Nil
Timepoint [1] 299838 0
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?
No
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] 286233 0
University
Name [1] 286233 0
University of Queensland, Cardiovascular Imaging Research Centre, School of Medicine
Country [1] 286233 0
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] 285043 0
Individual
Name [1] 285043 0
Dr Brian Haluska
Address [1] 285043 0
School of Medicine, University of Queensland
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country [1] 285043 0
Australia
Other collaborator category [1] 277144 0
Individual
Name [1] 277144 0
Prof Thomas Marwick
Address [1] 277144 0
Menzies Institute
Medical Science 1

17 Liverpool Street

Hobart TAS 7000

Australia

Postal Address:
Private Bag 23

Hobart TAS 7000

Australia
Country [1] 277144 0
Australia
Other collaborator category [2] 277145 0
Individual
Name [2] 277145 0
Prof John Prins
Address [2] 277145 0
Mater Medical Research Unit
Mater Hospital
550 Stanley Street
SOUTH BRISBANE QLD 4101
Country [2] 277145 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288314 0
Metro South Hospital and Health Service HREC
Ethics committee address [1] 288314 0
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Ethics committee country [1] 288314 0
Australia
Date submitted for ethics approval [1] 288314 0
Approval date [1] 288314 0
19/09/2012
Ethics approval number [1] 288314 0
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 34893 0
A/Prof Tony Stanton
Address 34893 0
Cardiovascular Imaging Research Centre
University of Queensland School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 34893 0
Australia
Phone 34893 0
+61 7 3176 5813
Fax 34893 0
+61 7 3176 5399
Email 34893 0
[email protected]
Contact person for public queries
Name 18140 0
Julie Holliday
Address 18140 0
School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 18140 0
Australia
Phone 18140 0
+61731766146
Fax 18140 0
+61731765399
Email 18140 0
[email protected]
Contact person for scientific queries
Name 9068 0
A/Prof Tony Stanton
Address 9068 0
School of Medicine
Princess Alexandra Hospital
Ipswich Road
WOOLLOONGABBA QLD 4102
Country 9068 0
Australia
Phone 9068 0
+61731765813
Fax 9068 0
+61731765399
Email 9068 0
[email protected]

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
EmbaseSubclinical LV dysfunction and 10-year outcomes in type 2 diabetes mellitus.2015https://dx.doi.org/10.1136/heartjnl-2014-307391
N.B. These documents automatically identified may not have been verified by the study sponsor.