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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telmisartan<br>One 40mg telmisartan pill given once daily for 24 months | Drug: Telmisartan<br> <br> |
| Placebo Comparator: Placebo<br>One 40mg placebo pill given once daily for 24 months | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA) |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 |  | Comparison between baseline and 2 years (24 months) following enrollment | 
| Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL) |  | Comparison between baseline and 24 months between the two groups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm, AAA, telmisartan