Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
NCT ID: NCT01683084
Last Updated: 2020-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
22 participants
INTERVENTIONAL
2012-09-19
2018-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Telmisartan
One 40mg telmisartan pill given once daily for 24 months
Telmisartan
Placebo
One 40mg placebo pill given once daily for 24 months
Placebo
Interventions
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Telmisartan
Placebo
Eligibility Criteria
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Inclusion Criteria
* AAA measuring a maximum diameter of 3.5-4.9 cm on CTA or ultrasound
* Stable medication regime for the last six months
* No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year
* High likelihood of compliance with treatment over 24 months
Exclusion Criteria
* Known significant renal stenosis (\>70%) of one or both renal arteries
* Chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN)
* Electrolyte imbalance
* Active gout
* Current or planned usage of an AT1 blocker or ACE inhibitor
* Previous abdominal aortic surgery
* Currently pregnant or intend to become pregnant
50 Years
85 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
James Cook University, Queensland, Australia
OTHER
Palo Alto Veterans Institute for Research
OTHER
Responsible Party
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Ronald L. Dalman, MD
Chidester Professor of Surgery and Chief, Stanford Vascular Surgery
Principal Investigators
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Ronald L Dalman, M.D.
Role: PRINCIPAL_INVESTIGATOR
PAIRE: Stanford University, VA Palo Alto Health Care System
Locations
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VA Palo Alto Health Care System
Palo Alto, California, United States
Countries
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References
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Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation. 2008 Dec 2;118(23):2382-92. doi: 10.1161/CIRCULATIONAHA.108.802074. No abstract available.
Golledge J, Pinchbeck J, Tomee SM, Rowbotham SE, Singh TP, Moxon JV, Jenkins JS, Lindeman JH, Dalman RL, McDonnell L, Fitridge R, Morris DR; TEDY Investigators. Efficacy of Telmisartan to Slow Growth of Small Abdominal Aortic Aneurysms: A Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1374-1381. doi: 10.1001/jamacardio.2020.3524.
Xuan H, Xu B, Wang W, Tanaka H, Fujimura N, Miyata M, Michie SA, Dalman RL. Inhibition or deletion of angiotensin II type 1 receptor suppresses elastase-induced experimental abdominal aortic aneurysms. J Vasc Surg. 2018 Feb;67(2):573-584.e2. doi: 10.1016/j.jvs.2016.12.110. Epub 2017 Apr 20.
Morris DR, Cunningham MA, 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. TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial. Trials. 2015 Jun 17;16:274. doi: 10.1186/s13063-015-0793-z.
Other Identifiers
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22647
Identifier Type: OTHER
Identifier Source: secondary_id
DAL0041ARG
Identifier Type: -
Identifier Source: org_study_id
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