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

NCT01683084 | Completed Phase 4 FDA Drug

• 2 other identifiers: DAL0041ARG22647
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal Aortic Aneurysm; AAA; telmisartan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound

  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

  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.

Study Arms (2)

Telmisartan

ACTIVE COMPARATOR

One 40mg telmisartan pill given once daily for 24 months

Drug: Telmisartan

Placebo

PLACEBO COMPARATOR

One 40mg placebo pill given once daily for 24 months

Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Medtronic: collaborator
• James Cook University, Queensland, Australia: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (4)

• 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. No abstract available.

  PMID: 19047592 BACKGROUND

• Golledge J, Pinchbeck J, Tomee SM, Rowbotham SE, Singh TP, Moxon JV, Jenkins JS, Lindeman JH, Dalman RL, McDonnell L, Fitridge R, Morris DR; TEDY Investigators. Efficacy of Telmisartan to Slow Growth of Small Abdominal Aortic Aneurysms: A Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1374-1381. doi: 10.1001/jamacardio.2020.3524.

  PMID: 32845283 DERIVED

• Xuan H, Xu B, Wang W, Tanaka H, Fujimura N, Miyata M, Michie SA, Dalman RL. Inhibition or deletion of angiotensin II type 1 receptor suppresses elastase-induced experimental abdominal aortic aneurysms. J Vasc Surg. 2018 Feb;67(2):573-584.e2. doi: 10.1016/j.jvs.2016.12.110. Epub 2017 Apr 20.

  PMID: 28434702 DERIVED

• Morris DR, Cunningham MA, Ahimastos AA, Kingwell BA, Pappas E, Bourke M, Reid CM, Stijnen T, Dalman RL, Aalami OO, Lindeman JH, Norman PE, Walker PJ, Fitridge R, Bourke B, Dear AE, Pinchbeck J, Jaeggi R, Golledge J. TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial. Trials. 2015 Jun 17;16:274. doi: 10.1186/s13063-015-0793-z.

  PMID: 26081587 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronald L Dalman, M.D.

  PAIRE: Stanford University, VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chidester Professor of Surgery and Chief, Stanford Vascular Surgery

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 11, 2012
• Study Start: September 19, 2012
• Primary Completion: November 10, 2018
• Study Completion: November 10, 2018
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

US (1)