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Completed

NCT Number: NCT01683084

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

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

  • James Cook University, Queensland, Australia
  • Medtronic

Registry information

Acronym: TEDY

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2012
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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