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Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms (TEDY)

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ClinicalTrials.gov Identifier: NCT01683084
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : December 25, 2018
Sponsor:
Collaborators:
Medtronic
James Cook University, Queensland, Australia
Information provided by (Responsible Party):
Ronald L. Dalman, MD, Palo Alto Veterans Institute for Research

Tracking Information
First Submitted Date  ICMJE September 5, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date December 25, 2018
Actual Study Start Date  ICMJE September 19, 2012
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA) [ Time Frame: 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01683084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
  • Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound [ Time Frame: Comparison between two groups at baseline and two years. ]
    Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.
  • Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples [ Time Frame: Comparison between baseline and 2 years (24 months) following enrollment ]
  • Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL) [ Time Frame: Comparison between baseline and 24 months between the two groups. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
Official Title  ICMJE Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Aortic Aneurysm
Intervention  ICMJE
  • Drug: Telmisartan
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Telmisartan
    One 40mg telmisartan pill given once daily for 24 months
    Intervention: Drug: Telmisartan
  • Placebo Comparator: Placebo
    One 40mg placebo pill given once daily for 24 months
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2012)
40
Actual Study Completion Date  ICMJE October 2, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01683084
Other Study ID Numbers  ICMJE DAL0041ARG
22647 ( Other Identifier: Stanford IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald L. Dalman, MD, Palo Alto Veterans Institute for Research
Study Sponsor  ICMJE Palo Alto Veterans Institute for Research
Collaborators  ICMJE
  • Medtronic
  • James Cook University, Queensland, Australia
Investigators  ICMJE
Principal Investigator: Ronald L Dalman, M.D. PAIRE: Stanford University, VA Palo Alto Health Care System
PRS Account Palo Alto Veterans Institute for Research
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP