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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12611000931976
Date of registration:	30/08/2011
Prospective Registration:	Yes
Primary sponsor:	James Cook University
Public title:	Telmisartan in the management of abdominal aortic aneurysm
Scientific title:	The effects of Telmisartan, an angiotensinII type 1 receptor blocker, in reducing AAA growth in patients with abdominal aortic aneurysm.
Date of first enrolment:	09/09/2011
Target sample size:	300
Recruitment status:	Stopped early
URL:	https://anzctr.org.au/ACTRN12611000931976.aspx
Study type:	Interventional
Study design:	Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
Phase:	Phase 2

Countries of recruitment
Australia	Netherlands	United States of America

Contacts

Name:	Ms Jenna Pinchbeck
Address:	Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Douglas, QLD, 4814 Australia
Telephone:	+61 7 4781 5449
Email:	jenna.pinchbeck@jcu.edu.au
Affiliation:

Name:	Prof Jonathan Golledge
Address:	Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Douglas, QLD, 4814 Australia
Telephone:	+61 7 47814730
Email:	jonathan.golledge@jcu.edu.au
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: 1. Written informed consent 2. Infra-renal AAA measuring a maximum orthogonal diameter greater than or equal to 35mm and less than or equal to 49mm on CTA or ultrasound; 3. Stable medication regime for the last 6 months; 4. No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year; 5. High likelihood of compliance with treatment over 24 months.
Exclusion criteria: Contraindications to study treatment, including: 1. renal impairment (i.e. creatinine >1.5x upper limit of normal [ULN]), 2. known significant renal stenosis (>70%) of one or both renal arteries, 3. chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN), 4. electrolyte imbalance and 5. active gout; 6. Current or planned usage of an AT1 blocker 7. Current or planned usage of an ACE inhibitor. 8. If the patient has previously had abdominal aortic surgery

Age minimum: 40 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

Abdominal Aortic Aneurysm;
Abdominal Aortic Aneurysm

Intervention(s)

Angiotensin II type 1 receptor blocker, oral tablet, 40mg daily for 24 months.

Primary Outcome(s)

Change in AAA growth as measured by maximum diameter on ultrasound[Ultrasound measurment conducted at entry, 6, 12, 18 and 24 months.]

Secondary Outcome(s)

Requirement of AAA surgery assessed by records of hospitalisations due to AAA surgery captured via serious adverse event documentation.[Requirement of AAA surgery will be assessed during every time point of the study, baseline, 3 month, and 6 monthly up to 24 months. ]

Changes in maximum orthogonal AAA diameter and total infrarenal aortic volume on Computer Tomography (CT)[CT measurements will be taken at baseline, 12 months and 24 months. ]

Change in resting brachial blood pressure measured with sphygmomanometer[Resting blood pressure to be measured at entry, 3, 6, 12, 18 and 24 months.]

AAA biomarker concentrations.[Blood collection (SST tubes x 2, EDTA tubes x 2, Citrate tube x 1, PaxGene tube x 1) to be undertaken at entry, 6, 12, 18 and 24 months.]

SF36 quality of life questionnaire.[SF-36 questionnaires to be collected at entry, 12 and 24 months.]

Secondary ID(s)

ClinicalTrials.gov: NCT01683084

Source(s) of Monetary Support

BUPA

NHMRC

Queensland Health

Secondary Sponsor(s)

Ethics review