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

Palo Alto Veterans Institute for Research22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Abdominal Aortic Aneurysm

Interventions

TelmisartanDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Palo Alto Health Care System

Palo Alto, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Comparison between two groups at baseline and two years.

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.

Data from ClinicalTrials.gov

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