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Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms (TEDY)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Telmisartan
Placebo
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal Aortic Aneurysm, AAA, telmisartan

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Telmisartan

Placebo

Arm Description

One 40mg telmisartan pill given once daily for 24 months

One 40mg placebo pill given once daily for 24 months

Outcomes

Primary Outcome Measures

Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)

Secondary Outcome Measures

Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.
Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples
Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)

Full Information

First Posted
September 5, 2012
Last Updated
May 21, 2020
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
Medtronic, James Cook University, Queensland, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01683084
Brief Title
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
Acronym
TEDY
Official Title
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 19, 2012 (Actual)
Primary Completion Date
November 10, 2018 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
Medtronic, James Cook University, Queensland, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
Abdominal Aortic Aneurysm, AAA, telmisartan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan
Arm Type
Active Comparator
Arm Description
One 40mg telmisartan pill given once daily for 24 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One 40mg placebo pill given once daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)
Time Frame
Patients will be followed for two years following enrollment, with AAA growth determined by comparing total AAA volume at baseline and at two years between control and treatment groups.
Secondary Outcome Measure Information:
Title
Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
Description
Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.
Time Frame
Comparison between two groups at baseline and two years.
Title
Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples
Time Frame
Comparison between baseline and 2 years (24 months) following enrollment
Title
Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)
Time Frame
Comparison between baseline and 24 months between the two groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald L Dalman, M.D.
Organizational Affiliation
PAIRE: Stanford University, VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19047592
Citation
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.
Results Reference
background
PubMed Identifier
32845283
Citation
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.
Results Reference
derived
PubMed Identifier
28434702
Citation
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.
Results Reference
derived
PubMed Identifier
26081587
Citation
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. Erratum In: Trials. 2016;17:43.
Results Reference
derived

Learn more about this trial

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

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