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

This study is currently recruiting participants.
Verified May 2013 by Palo Alto Institute for Research and Education, Inc
Sponsor:
Information provided by (Responsible Party):
Ronald L. Dalman, MD, Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT01683084
First received: September 5, 2012
Last updated: May 28, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Abdominal Aortic Aneurysm
 Drug: Telmisartan
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms

Resource links provided by NLM:

Drug Information available for: Telmisartan
U.S. FDA Resources

Further study details as provided by Palo Alto Institute for Research and Education, Inc:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound [ Time Frame: Comparison between two groups at baseline and two years. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Comparison between baseline and 2 years (24 months) following enrollment ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telmisartan
One 40mg telmisartan pill given once daily for 24 months
 Drug: Telmisartan
Placebo Comparator: Placebo
One 40mg placebo pill given once daily for 24 months
 Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683084

Contacts
Contact: Lori K McDonnell, M.A. 650-493-5000 ext 1-1-62370 lorimcd2@stanford.edu

Locations
United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Sub-Investigator: Oliver O Aalami, M.D.            
Sponsors and Collaborators
Ronald L. Dalman, MD
Investigators
Principal Investigator: Ronald L Dalman, M.D. PAIRE: Stanford University, VA Palo Alto Health Care System
  More Information

Publications:

Responsible Party: Ronald L. Dalman, MD, Chidester Professor of Surgery and Chief, Stanford Vascular Surgery, Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier: NCT01683084     History of Changes
Other Study ID Numbers: DAL0041ARG, 22647
Study First Received: September 5, 2012
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Institute for Research and Education, Inc:
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Telmisartan
Benzoates
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013