title: TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. dylan.morris@my.jcu.edu.au.
authors.forename: Dylan R
authors.initials: DR
authors.lastname: Morris
authors.affiliation: Psychology Department, University of Stirling, Stirling, UK. margaret.cunningham@stir.ac.uk.
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Cunningham
authors.affiliation: Baker IDI Heart and Diabetes Institute and The Department of Cardiovascular Medicine, Alfred Hospital Melbourne, Melbourne, Australia. A.Ahimastos@alfred.org.au.
authors.forename: Anna A
authors.initials: AA
authors.lastname: Ahimastos
authors.affiliation: Baker IDI Heart and Diabetes Institute and The Department of Cardiovascular Medicine, Alfred Hospital Melbourne, Melbourne, Australia. Bronwyn.Kingwell@bakeridi.edu.au.
authors.forename: Bronwyn A
authors.initials: BA
authors.lastname: Kingwell
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. elise.pappas@jcu.edu.au.
authors.forename: Elise
authors.initials: E
authors.lastname: Pappas
authors.affiliation: Gosford Vascular Services, Gosford, New South Wales, Australia. michaelbourke85@gmail.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Bourke
authors.affiliation: Centre of Cardiovascular Research and Education in Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, Australia. chris.reid@monash.edu.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Reid
authors.affiliation: Leiden University Medical Center, Leiden, The Netherlands. T.Stijnen@lumc.nl.
authors.forename: Theo
authors.initials: T
authors.lastname: Stijnen
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, CA, USA. rld@stanford.edu.
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Dalman
authors.affiliation: Division of Vascular Surgery, Department of Surgery, Stanford University School of Medicine, Stanford, CA, USA. aalami@stanford.edu.
authors.forename: Oliver O
authors.initials: OO
authors.lastname: Aalami
authors.affiliation: Leiden University Medical Center, Leiden, The Netherlands. J.H.N.Lindeman@lumc.nl.
authors.forename: Jan H
authors.initials: JH
authors.lastname: Lindeman
authors.affiliation: School of Surgery, University of Western Australia, Perth, WA, Australia. paul.norman@uwa.edu.au.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Norman
authors.affiliation: 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.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Walker
authors.affiliation: Department of Surgery, University of Adelaide, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia. robert.fitridge@adelaide.edu.au.
authors.forename: Robert
authors.initials: R
authors.lastname: Fitridge
authors.affiliation: Gosford Vascular Services, Gosford, New South Wales, Australia. dr.bourke@gvs.com.au.
authors.forename: Bernie
authors.initials: B
authors.lastname: Bourke
authors.affiliation: Eastern Health Clinical School, Department of Medicine, Monash University, Melbourne, Australia. anthony.dear@monash.edu.
authors.forename: Anthony E
authors.initials: AE
authors.lastname: Dear
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. Jenna.pinchbeck@jcu.edu.au.
authors.forename: Jenna
authors.initials: J
authors.lastname: Pinchbeck
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. rene.jaeggi@jcu.edu.au.
authors.forename: Rene
authors.initials: R
authors.lastname: Jaeggi
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia. jonathan.golledge@jcu.edu.au.|The Department of Vascular and Endovascular Surgery, The Townsville Hospital, Townsville, QLD, Australia. jonathan.golledge@jcu.edu.au.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Golledge
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D017544:Aortic Aneurysm, Abdominal / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D001027:Aortography / Q000379:methods; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001565:Benzoates / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D002985:Clinical Protocols; D018450:Disease Progression; D004311:Double-Blind Method; D006801:Humans; D057194:Intention to Treat Analysis; D011788:Quality of Life; D011793:Queensland; D012107:Research Design; D000077333:Telmisartan; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D015415:Biomarkers; D000077333:Telmisartan