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

Morris, Dylan, 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 Louise, 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. 274. pp. 1-10.

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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.

Item ID: 41738
Item Type: Article (Research - C1)
ISSN: 1745-6215
Keywords: abdominal aortic aneurysm; trial; angiotensin; telmisartan
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Copyright © 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.

The Erratum to this article has been published in Trials 2016 17:43 at http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1183-x

Funders: National Health and Medical Research Council of Australia (NHMRC)., British United Provident Association Foundation, Queensland Government
Projects and Grants: NHMRC 1022752, NHMRC 1000967, NHMRC 1019921, NHMRC 526604
Date Deposited: 08 Dec 2015 14:33
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1102 Cardiovascular Medicine and Haematology > 110201 Cardiology (incl Cardiovascular Diseases) @ 70%
11 MEDICAL AND HEALTH SCIENCES > 1115 Pharmacology and Pharmaceutical Sciences > 111504 Pharmaceutical Sciences @ 30%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920103 Cardiovascular System and Diseases @ 100%
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