Clinical trial NCT01683084: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal Aortic Aneurysm
AAA
telmisartan
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: Medtronic
name: James Cook University, Queensland, Australia
First posted: 2012-09-11
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)
timeFrame: 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:
measure: Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
timeFrame: Comparison between two groups at baseline and two years.
measure: Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples
timeFrame: Comparison between baseline and 2 years (24 months) following enrollment
measure: Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)
timeFrame: Comparison between baseline and 24 months between the two groups.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: PAIRE: Stanford University, VA Palo Alto Health Care System
name: Ronald L Dalman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.