Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/24115
Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial
Authors: Morris, Dylan
Cunningham, Margaret
Ahimastos, Anna A
Kingwell, Bronwen 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
Contact Email: mc52@stir.ac.uk
Keywords: Abdominal aortic aneurysm
Trial
Angiotensin
Telmisartan
Issue Date: 17-Jun-2015
Publisher: BioMed Central
Citation: Morris D, Cunningham M, Ahimastos AA, Kingwell BA, Pappas E, Bourke M, Reid CM, Stijnen T, Dalman RL, Aalami OO, Lindeman JH, Norman PE, Walker PJ, Fitridge R, Bourke B, Dear AE, Pinchbeck J, Jaeggi R & Golledge J (2015) TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial, Trials, 16, Art. No.: 274.
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 RegistryACTRN12611000931976, registered on 30 August 2011; Stanford study centre: clinicaltrials.govNCT01683084, registered on 5 September 2012.
Type: Journal Article
URI: http://hdl.handle.net/1893/24115
DOI Link: http://dx.doi.org/10.1186/s13063-015-0793-z
Rights: © Morris et al. 2016 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Affiliation: James Cook University
NMAHP Research
Baker IDI Heart & Diabetes Institute
Baker IDI Heart & Diabetes Institute
James Cook University
Gosford Vascular Services Pty Ltd
Monash University
Leiden University
Stanford University
Stanford University
Leiden University
University of Western Australia
James Cook University
University of Adelaide
Gosford Vascular Services Pty Ltd
Monash University
James Cook University
James Cook University
James Cook University

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