Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms

NCT ID: NCT01683084

Last Updated: 2020-05-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-19

Study Completion Date

2018-11-10

Brief Summary

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The purpose of this study is to determine if telmisartan is effective in slowing the progression of abdominal aortic aneurysms and reducing circulating concentrations of Abdominal Aortic Aneurysms (AAA) biomarkers.

Detailed Description

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Currently, the only management options for AAA are surgical (open or endovascular) based on ongoing follow-up with imaging at regular intervals. Telmisartan is currently approved for use in the United States by the Food and Drug Administration for management of hypertension. If telmisartan is found to be effective in slowing the progression of abdominal aortic aneurysms, this would provide a new treatment option for patients with AAA disease.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Telmisartan

One 40mg telmisartan pill given once daily for 24 months

Group Type ACTIVE_COMPARATOR

Telmisartan

Intervention Type DRUG

Placebo

One 40mg placebo pill given once daily for 24 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Telmisartan

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 50-85 years of age and able to provide written informed consent
* 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

* Renal impairment (i.e. creatinine \>1.5x upper limit of normal \[ULN\])
* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

James Cook University, Queensland, Australia

OTHER

Sponsor Role collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Ronald L. Dalman, MD

Chidester Professor of Surgery and Chief, Stanford Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 19047592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32845283 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28434702 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26081587 (View on PubMed)

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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