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.
|
