Brief Title
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
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 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)
Secondary Outcome
Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
Condition
Abdominal Aortic Aneurysm
Intervention
Telmisartan
Study Arms / Comparison Groups
Telmisartan
Description: One 40mg telmisartan pill given once daily for 24 months
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
22
Start Date
September 19, 2012
Completion Date
November 10, 2018
Primary Completion Date
November 10, 2018
Eligibility Criteria
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
Gender
All
Ages
50 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Ronald L Dalman, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01683084
Organization ID
DAL0041ARG
Secondary IDs
22647
Responsible Party
Principal Investigator
Study Sponsor
Palo Alto Veterans Institute for Research
Collaborators
Medtronic
Study Sponsor
Ronald L Dalman, M.D., Principal Investigator, PAIRE: Stanford University, VA Palo Alto Health Care System
Verification Date
May 2020