Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
This trial is active, not recruiting.
|Condition||abdominal aortic aneurysm|
|Sponsor||Ronald L. Dalman, MD|
|Start date||September 2012|
|End date||April 2016|
|Trial size||22 participants|
|Trial identifier||NCT01683084, 22647, DAL0041ARG|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
One 40mg telmisartan pill given once daily for 24 months
One 40mg placebo pill given once daily for 24 months
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.
Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
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.
Male or female participants from 50 years up to 85 years old.
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
|Official title||Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms|
|Principal investigator||Ronald L Dalman, M.D.|
|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.|
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