TElmisartan in the management of abDominal aortic aneurYsm (TEDY): the study protocol for a randomized controlled trial

Morris, Dylan R., Cunningham, Margaret A., Ahimastos, Anna A., Kingwell, Bronwyn A., Pappas, Elise, Bourke, Michael, Reid, Christopher M., Stijnen, Theo, Dalman, Ronald L., Aalami, Oliver O., Lindeman, Jan H., Norman, Paul E., Walker, Philip J., Fitridge, Robert, Bourke, Bernie, Dear, Anthony E., Pinchbeck, Jenna, Jaeggi, Rene and Golledge, Jonathan (2015) TElmisartan in the management of abDominal aortic aneurYsm (TEDY): the study protocol for a randomized controlled trial. Trials, 16 1: 1-10. doi:10.1186/s13063-015-0793-z


Author Morris, Dylan R.
Cunningham, Margaret A.
Ahimastos, Anna A.
Kingwell, Bronwyn A.
Pappas, Elise
Bourke, Michael
Reid, Christopher M.
Stijnen, Theo
Dalman, Ronald L.
Aalami, Oliver O.
Lindeman, Jan H.
Norman, Paul E.
Walker, Philip J.
Fitridge, Robert
Bourke, Bernie
Dear, Anthony E.
Pinchbeck, Jenna
Jaeggi, Rene
Golledge, Jonathan
Title TElmisartan in the management of abDominal aortic aneurYsm (TEDY): the study protocol for a randomized controlled trial
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
1468-6708
Publication date 2015-06-17
Sub-type Article (original research)
DOI 10.1186/s13063-015-0793-z
Open Access Status DOI
Volume 16
Issue 1
Start page 1
End page 10
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2016
Language eng
Formatted abstract
Background:  Experimental studies suggest that angiotensin II plays a central role in the pathogenesis of abdominal aortic aneurysm. This trial aims to evaluate the efficacy of the angiotensin receptor blocker telmisartan in limiting the progression of abdominal aortic aneurysm.

Methods/design:  Telmisartan in the management of abdominal aortic aneurysm (TEDY) is a multicentre, parallel-design, randomised, double-blind, placebo-controlled trial with an intention-to-treat analysis. We aim to randomly assign 300 participants with small abdominal aortic aneurysm to either 40 mg of telmisartan or identical placebo and follow patients over 2 years. The primary endpoint will be abdominal aortic aneurysm growth as measured by 1) maximum infra-renal aortic volume on computed tomographic angiography, 2) maximum orthogonal diameter on computed tomographic angiography, and 3) maximum diameter on ultrasound. Secondary endpoints include change in resting brachial blood pressure, abdominal aortic aneurysm biomarker profile and health-related quality of life. TEDY is an international collaboration conducted from major vascular centres in Australia, the United States and the Netherlands.

Discussion:  Currently, no medication has been convincingly demonstrated to limit abdominal aortic aneurysm progression. TEDY will examine the potential of a promising treatment strategy for patients with small abdominal aortic aneurysms.

Trial registration:  Australian and Leiden study centres: Australian New Zealand Clinical Trials Registry ACTRN12611000931976, registered on 30 August 2011; Stanford study centre: clinicaltrials.gov NCT01683084, registered on 5 September 2012.
Keyword Abdominal aortic aneurysm
Angiotensin
Telmisartan
Trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
Official 2016 Collection
School of Medicine Publications
 
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