Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal Aortic Aneurysm, AAA, telmisartan
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 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.
Interventions
DRUGTelmisartan
DRUGPlacebo
Sponsors
Medtronic
James Cook University, Queensland, Australia
Palo Alto Veterans Institute for Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound | 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 | 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. | — |
Countries
United States
Outcome results
None listed