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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Dylan R. Morris, Margaret A. Cunningham, Anna A. Ahimastos, Bronwyn A. Kingwell, Elise Pappas, Michael Bourke, Christopher M. Reid, Theo Stijnen, Ronald L. Dalman, Oliver O. Aalami, Jan H. Lindeman, Paul E. Norman, Philip J. Walker, Robert Fitridge, Bernie Bourke, Anthony E. Dear, Jenna Pinchbeck, Rene Jaeggi, Jonathan Golledge

Published in: Trials | Issue 1/2015

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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 ACTRN12611000931​976, registered on 30 August 2011; Stanford study centre: clinicaltrials.gov NCT01683084, registered on 5 September 2012.
Appendix
Available only for authorised users
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Metadata
Title
TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial
Authors
Dylan R. Morris
Margaret A. Cunningham
Anna A. Ahimastos
Bronwyn A. Kingwell
Elise Pappas
Michael Bourke
Christopher M. Reid
Theo Stijnen
Ronald L. Dalman
Oliver O. Aalami
Jan H. Lindeman
Paul E. Norman
Philip J. Walker
Robert Fitridge
Bernie Bourke
Anthony E. Dear
Jenna Pinchbeck
Rene Jaeggi
Jonathan Golledge
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0793-z

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