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

Not Applicable

Completed

• Conditions: Diabetic cardiomyopathy; Cardiovascular - Coronary heart disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612001178831
• Lead Sponsor: Dr Tony Stanton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Participation will be invited from all surviving participants of the original study commenced in 2003.

-Age >18 years, and <85 years
-Diagnosed with type 2 diabetes
-Appropriate informed consent obtained and signed

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major cardiac adverse events (MACE), and complications related to T2DM - as assessed by data linkage to medical records.[From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012];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.[From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012];That ACE inhibitor/ARB therapy and/or beta-blocker therapy will prevent progression of diabetic cardiomyopathy. <br>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.[From commencement of original study in 2003 which provided 3 years of data, to 30th June 2012]

Secondary Outcome Measures

Name	Time	Method
il[Nil]