Clinical Trial: Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms

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 Summary: 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.
Sponsor: Ronald L. Dalman, MD

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]


Original Secondary Outcome: Same as current

Information By: Palo Alto Veterans Institute for Research

Dates:
Date Received: September 5, 2012
Date Started: September 2012
Date Completion: August 2017
Last Updated: April 3, 2017
Last Verified: April 2017