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Trial registered on ANZCTR


Registration number
ACTRN12611000931976
Ethics application status
Approved
Date submitted
19/08/2011
Date registered
30/08/2011
Date last updated
8/10/2019
Date data sharing statement initially provided
7/08/2019
Date results information initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 262875 0
ClinicalTrials.gov: NCT01683084
Universal Trial Number (UTN)
U1111-1119-8488
Trial acronym
TEDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 261285 0
Condition category
Condition code
Cardiovascular 259433 259433 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Angiotensin II type 1 receptor blocker, oral tablet, 40mg daily for 24 months.
Intervention code [1] 264137 0
Treatment: Drugs
Comparator / control treatment
Placebo, sugar pill that is identical in appearance to Telmisartan but without the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 262240 0
Change in AAA growth as measured by maximum diameter on ultrasound
Timepoint [1] 262240 0
Ultrasound measurment conducted at entry, 6, 12, 18 and 24 months.
Secondary outcome [1] 273371 0
Change in resting brachial blood pressure measured with sphygmomanometer
Timepoint [1] 273371 0
Resting blood pressure to be measured at entry, 3, 6, 12, 18 and 24 months.
Secondary outcome [2] 287770 0
SF36 quality of life questionnaire.
Timepoint [2] 287770 0
SF-36 questionnaires to be collected at entry, 12 and 24 months.
Secondary outcome [3] 287771 0
AAA biomarker concentrations.
Timepoint [3] 287771 0
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.
Secondary outcome [4] 375578 0
Changes in maximum orthogonal AAA diameter and total infrarenal aortic volume on Computer Tomography (CT)
Timepoint [4] 375578 0
CT measurements will be taken at baseline, 12 months and 24 months.
Secondary outcome [5] 375579 0
Requirement of AAA surgery assessed by records of hospitalisations due to AAA surgery captured via serious adverse event documentation.
Timepoint [5] 375579 0
Requirement of AAA surgery will be assessed during every time point of the study, baseline, 3 month, and 6 monthly up to 24 months.

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised by a blinded health professional through the secure trial website, coordinated by an independent trial centre. Random number sequences will correspond to serial numbers on concealed study packaging.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation by the online randomisation website (ccre.med.monash.edu.au/TEDYrand).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 4490 0
Mackay Base Hospital - Mackay
Recruitment hospital [2] 14933 0
The Townsville Hospital - Douglas
Recruitment hospital [3] 14934 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 14935 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 14936 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 7175 0
3128 - Box Hill
Recruitment postcode(s) [2] 7176 0
2250 - Gosford
Recruitment postcode(s) [3] 7177 0
5011 - Woodville South
Recruitment postcode(s) [4] 10677 0
4740 - Mackay
Recruitment postcode(s) [5] 10678 0
3181 - Prahran
Recruitment postcode(s) [6] 10679 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [7] 10680 0
4811 - James Cook University
Recruitment postcode(s) [8] 10681 0
4812 - Pimlico
Recruitment postcode(s) [9] 10682 0
4814 - Douglas
Recruitment postcode(s) [10] 10683 0
6160 - Fremantle
Recruitment postcode(s) [11] 28204 0
4029 - Herston
Recruitment postcode(s) [12] 28205 0
5011 - Woodville
Recruitment postcode(s) [13] 28206 0
4810 - Pimlico
Recruitment outside Australia
Country [1] 5229 0
United States of America
State/province [1] 5229 0
California
Country [2] 5230 0
Netherlands
State/province [2] 5230 0
Leiden

Funding & Sponsors
Funding source category [1] 269698 0
Other
Name [1] 269698 0
BUPA
Address [1] 269698 0
Bupa Australia
600 Glenferrie Rd
Hawthorn
Victoria
3122
Country [1] 269698 0
Australia
Funding source category [2] 287633 0
Government body
Name [2] 287633 0
NHMRC
Address [2] 287633 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 287633 0
Australia
Funding source category [3] 287634 0
Government body
Name [3] 287634 0
Queensland Health
Address [3] 287634 0
Queensland Health
147-163 Charlotte Street
Brisbane Queensland 4000
Country [3] 287634 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook Drive
Douglas, Townsville
Queensland 4811
Country
Australia
Secondary sponsor category [1] 268734 0
None
Name [1] 268734 0
Address [1] 268734 0
Country [1] 268734 0
Other collaborator category [1] 252211 0
Hospital
Name [1] 252211 0
Townsville Hospital
Address [1] 252211 0
100 Angus Smith Dr,
Douglas QLD 4814
Country [1] 252211 0
Australia
Other collaborator category [2] 252212 0
Hospital
Name [2] 252212 0
Mater Health Services NQ Ltd
Address [2] 252212 0
21-37 Fulham Rd,
Pimlico
Queensland QLD 4812
Country [2] 252212 0
Australia
Other collaborator category [3] 252213 0
Hospital
Name [3] 252213 0
Royal Brisbane Women's Hospital
Address [3] 252213 0
Cnr Butterfield and Bowen Bridge Rd
Brisbane
Queensland 4029
Country [3] 252213 0
Australia
Other collaborator category [4] 252214 0
Hospital
Name [4] 252214 0
Fremantle Hospital
Address [4] 252214 0
Alma St,
Fremantle
Western Australia 6959
Country [4] 252214 0
Australia
Other collaborator category [5] 252215 0
Hospital
Name [5] 252215 0
Alfred Hospital
Address [5] 252215 0
Commercial Road
Prahran
Victoria 3181
Country [5] 252215 0
Australia
Other collaborator category [6] 277243 0
Hospital
Name [6] 277243 0
The Queen Elizabeth Hospital
Address [6] 277243 0
28 Woodville Road,
Woodville South,
SA 5011 AUSTRALIA
Country [6] 277243 0
Australia
Other collaborator category [7] 277524 0
Other Collaborative groups
Name [7] 277524 0
Gosford Vascular Services
Address [7] 277524 0
213 Albany St
Gosford
NSW 2250
Country [7] 277524 0
Australia
Other collaborator category [8] 277525 0
Hospital
Name [8] 277525 0
Box Hill Hospital
Address [8] 277525 0
Nelson Rd, Box Hill
VIC 3128
Country [8] 277525 0
Australia
Other collaborator category [9] 277526 0
Hospital
Name [9] 277526 0
Leiden University Medical Center
Address [9] 277526 0
Leiden University Medical Center
Albinusdreef 2
2333 ZA Leiden, Netherlands
Country [9] 277526 0
Netherlands
Other collaborator category [10] 277527 0
Hospital
Name [10] 277527 0
Veterans Administration Hospital & Stanford University
Address [10] 277527 0
3801 Miranda Ave
Palo Alto CA 94304, United States
Country [10] 277527 0
United States of America
Other collaborator category [11] 278673 0
Hospital
Name [11] 278673 0
Mackay Base Hospital
Address [11] 278673 0
475 Bridge Road
West Mackay
Country [11] 278673 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271656 0
Townsville Health Service District
Ethics committee address [1] 271656 0
100 Angus Smith Dr
Douglas QLD 4814
Ethics committee country [1] 271656 0
Australia
Date submitted for ethics approval [1] 271656 0
08/01/2010
Approval date [1] 271656 0
12/04/2010
Ethics approval number [1] 271656 0
HREC/09/QTHS/117
Ethics committee name [2] 271657 0
JCU Human Research Ethics Committee
Ethics committee address [2] 271657 0
Douglas, Townsville
QLD 4811
Ethics committee country [2] 271657 0
Australia
Date submitted for ethics approval [2] 271657 0
Approval date [2] 271657 0
12/04/2010
Ethics approval number [2] 271657 0
C7
Ethics committee name [3] 271658 0
Mater Health Services NQ Ltd
Ethics committee address [3] 271658 0
21-37 Fulham Rd
Pimlico, Townsville
QLD 4812
Ethics committee country [3] 271658 0
Australia
Date submitted for ethics approval [3] 271658 0
Approval date [3] 271658 0
21/09/2010
Ethics approval number [3] 271658 0
EC00412
Ethics committee name [4] 271659 0
Alfred Hospital Ethics Committee
Ethics committee address [4] 271659 0
Commercial Road,
Melbourne
VIC 3181
Ethics committee country [4] 271659 0
Australia
Date submitted for ethics approval [4] 271659 0
25/02/2010
Approval date [4] 271659 0
20/05/2010
Ethics approval number [4] 271659 0
23/10/2010
Ethics committee name [5] 271660 0
Royal Brisbane and Women's Hospital Metro North Health Service District
Ethics committee address [5] 271660 0
Cnr Butterfield & Bowen Bridge Rd
Herston
QLD 4029
Ethics committee country [5] 271660 0
Australia
Date submitted for ethics approval [5] 271660 0
08/01/2010
Approval date [5] 271660 0
23/06/2010
Ethics approval number [5] 271660 0
HREC/10/WRBW/28
Ethics committee name [6] 271661 0
Government of Western Australia Department of Health South Metropolitan Area Health Service
Ethics committee address [6] 271661 0
Alma St
Fremantle
WA 6959
Ethics committee country [6] 271661 0
Australia
Date submitted for ethics approval [6] 271661 0
10/08/2010
Approval date [6] 271661 0
24/08/2010
Ethics approval number [6] 271661 0
1/10/0317

Summary
Brief summary
The primary purpose of the study is to investigate telmisartan as a novel therapy for patients with abdominal aortic aneurysms. We hypothesize that telmisartan will reduce AAA growth.
Trial website
http://ncre-pad.registry.org.au/clinical-studies/current-studies/lists/current-ncre-pad-studies/tedy
https://ccre.med.monash.edu.au/TedyRand/
Trial related presentations / publications
TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial
Dylan R. Morris†, Margaret A. Cunningham†, Anna A. Ahimastos†, Bronwyn A. Kingwell, Elise Pappas, Michael Bourke, Christopher M. Reid, Theo Stijnen, Ronald L. Dalman, Oliver O. Aalami, Jan H. Lindeman, Paul E. Norman, Philip J. Walker, Robert Fitridge, Bernie Bourke, Anthony E. Dear, Jenna Pinchbeck, Rene Jaeggi and Jonathan Golledge†Email author
†Contributed equally
Trials 201516:274
DOI: 10.1186/s13063-015-0793-z© Morris et al. 2016
Received: 17 March 2015 Accepted: 2 June 2015 Published: 17 June 2015
Public notes

Contacts
Principal investigator
Name 32293 0
Prof Jonathan Golledge
Address 32293 0
James Cook University
James Cook Drive
Townsville 4811
QLD
Country 32293 0
Australia
Phone 32293 0
+61 7 4433 1443
Fax 32293 0
+61 7 4433 1401
Email 32293 0
jonathan.golledge@jcu.edu.au
Contact person for public queries
Name 15540 0
Ms Jenna Pinchbeck
Address 15540 0
Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Douglas, QLD, 4814
Country 15540 0
Australia
Phone 15540 0
+61 7 4781 5449
Fax 15540 0
+61 7 4781 3652
Email 15540 0
jenna.pinchbeck@jcu.edu.au
Contact person for scientific queries
Name 6468 0
Prof Jonathan Golledge
Address 6468 0
Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, James Cook University, Douglas, QLD, 4814
Country 6468 0
Australia
Phone 6468 0
+61 7 47814730
Fax 6468 0
+61 7 4781 3652
Email 6468 0
jonathan.golledge@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be shared as this was not originally written in the study protocol. Our protocol does not have HREC approval for data sharing and this was not included in the PICF.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 3824 0
Study protocol
Citation [1] 3824 0
Morris, D.R., Cunningham, M.A., Ahimastos, A.A., Kingwell, B.A., Pappas, E., Bourke, M., Reid, C.M., Stijnen, T., Dalman, R.L., Aalami, O.O., Lindeman, J.H., Norman, P.E., Walker, P.J., Fitridge, R., Bourke, B., Dear, A.E., Pinchbeck, J., Jaeggi, R. & Golledge, J. (2015) "TElmisartan in the management of abDominal aortic aneurysm (TEDY): The study protocol for a randomized controlled trial", Trials, vol. 16, no. 1, pp. 274.
Link [1] 3824 0
Email [1] 3824 0
Other [1] 3824 0
Attachment [1] 3824 0
Type [2] 3825 0
Statistical analysis plan
Citation [2] 3825 0
Morris, D.R., Cunningham, M.A., Ahimastos, A.A., Kingwell, B.A., Pappas, E., Bourke, M., Reid, C.M., Stijnen, T., Dalman, R.L., Aalami, O.O., Lindeman, J.H., Norman, P.E., Walker, P.J., Fitridge, R., Bourke, B., Dear, A.E., Pinchbeck, J., Jaeggi, R. & Golledge, J. (2015) "TElmisartan in the management of abDominal aortic aneurysm (TEDY): The study protocol for a randomized controlled trial", Trials, vol. 16, no. 1, pp. 274.
Link [2] 3825 0
Email [2] 3825 0
Other [2] 3825 0
Attachment [2] 3825 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary