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

Abdominal Aortic Aneurysm Clinical Trial

— TEDY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683084
• Other study ID #: DAL0041ARG
• Secondary ID: 22647
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2012
• Est. completion date: November 10, 2018

Study information

• Verified date: May 2020
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 10, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Drug:
• Telmisartan

• Placebo

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	James Cook University, Queensland, Australia, Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation. 2008 Dec 2;118(23):2382-92. doi: 10.1161/CIRCULATIONAHA.108.802074. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound	Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.	Comparison between two groups at baseline and two years.
Secondary	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
Secondary	Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)		Comparison between baseline and 24 months between the two groups.