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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Ronald L. Dalman, MD, Palo Alto Veterans Institute for Research Identifier:
First received: September 5, 2012
Last updated: April 3, 2017
Last verified: April 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:

Further study details as provided by Palo Alto Veterans Institute for Research:

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. ]

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. ]
    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 ]
  • 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. ]

Enrollment: 22
Study Start Date: September 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: April 2017 (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.

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01683084

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Ronald L. Dalman, MD
Principal Investigator: Ronald L Dalman, M.D. PAIRE: Stanford University, VA Palo Alto Health Care System
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ronald L. Dalman, MD, Chidester Professor of Surgery and Chief, Stanford Vascular Surgery, Palo Alto Veterans Institute for Research Identifier: NCT01683084     History of Changes
Other Study ID Numbers: DAL0041ARG
22647 ( Other Identifier: Stanford IRB )
Study First Received: September 5, 2012
Last Updated: April 3, 2017

Keywords provided by Palo Alto Veterans Institute for Research:
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017