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

Phase 4

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Drug: Placebo; Drug: Telmisartan

• Registration Number: NCT01683084
• Lead Sponsor: Palo Alto Veterans Institute for Research

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 Timeline

• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-11
• Study Start: 2012-09-19
• Primary Completion: 2018-11-10
• Study Completion: 2018-11-10
• Disposition First Submitted: 2020-03-16
• Status Verified: 2020-05
• Disposition First Submitted QC: 2020-05-21
• Last Update Submitted: 2020-05-21
• Disposition First Posted: 2020-05-26
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One 40mg placebo pill given once daily for 24 months
Telmisartan	Telmisartan	One 40mg telmisartan pill given once daily for 24 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States