Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms (TEDY)

Palo Alto Veterans Institute for Research

Status and phase

Completed

Phase 4

Conditions

Abdominal Aortic Aneurysm

Treatments

Drug: Placebo

Drug: Telmisartan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01683084

22647 (Other Identifier)

DAL0041ARG

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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