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

Author(s): Morris DR(1), Cunningham MA(2), Ahimastos AA(3), Kingwell BA(4), Pappas E(5), Bourke M(6), Reid CM(7), Stijnen T(8), Dalman RL(9), Aalami OO(10), Lindeman JH(11), Norman PE(12), Walker PJ(13), Fitridge R(14), Bourke B(15), Dear AE(16), Pinchbeck J(17), Jaeggi R(18), Golledge J(19,)(20).

Affiliation(s): Author information: (1)Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. dylan.morris@my.jcu.edu.au. (2)Psychology Department, University of Stirling, Stirling, UK. margaret.cunningham@stir.ac.uk. (3)Baker IDI Heart and Diabetes Institute and The Department of Cardiovascular Medicine, Alfred Hospital Melbourne, Melbourne, Australia. A.Ahimastos@alfred.org.au. (4)Baker IDI Heart and Diabetes Institute and The Department of Cardiovascular Medicine, Alfred Hospital Melbourne, Melbourne, Australia. Bronwyn.Kingwell@bakeridi.edu.au. (5)Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. elise.pappas@jcu.edu.au. (6)Gosford Vascular Services, Gosford, New South Wales, Australia. michaelbourke85@gmail.com. (7)Centre of Cardiovascular Research and Education in Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia. chris.reid@monash.edu. (8)Leiden University Medical Center, Leiden, The Netherlands. T.Stijnen@lumc.nl. (9)Division of Vascular Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, CA, USA. rld@stanford.edu. (10)Division of Vascular Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, CA, USA. aalami@stanford.edu. (11)Leiden University Medical Center, Leiden, The Netherlands. J.H.N.Lindeman@lumc.nl. (12)School of Surgery, University of Western Australia, Perth, WA, Australia. paul.norman@uwa.edu.au. (13)University of Queensland School of Medicine, Discipline of Surgery and Centre for Clinical Research, and Department of Vascular Surgery, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia. p.walker@uq.edu.au. (14)Department of Surgery, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia. robert.fitridge@adelaide.edu.au. (15)Gosford Vascular Services, Gosford, New South Wales, Australia. dr.bourke@gvs.com.au. (16)Eastern Health Clinical School, Department of Medicine, Monash University, Melbourne, Australia. anthony.dear@monash.edu. (17)Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. Jenna.pinchbeck@jcu.edu.au. (18)Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. rene.jaeggi@jcu.edu.au. (19)Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. jonathan.golledge@jcu.edu.au. (20)The Department of Vascular and Endovascular Surgery, The Townsville Hospital, Townsville, QLD, Australia. jonathan.golledge@jcu.edu.au.

Publication date & source: 2015, Trials. , 16:274

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.

Page last updated: 2015-08-10

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