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Eplerenone in the Management of Abdominal Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT02345590
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
Baker IDI Heart and Diabetes Institute
Information provided by (Responsible Party):
Bayside Health

Brief Summary:

Weakening and expansion of the main abdominal artery (abdominal aortic aneurysm, AAA) is a common problem in older Australians. The majority of AAAs are small (<55 mm) and affect 90,000 individuals in Australia and 4.5 million world-wide. Currently, the only treatment available for AAA is surgery. However, surgical therapies are not effective for small AAAs, and these patients undergo a program of repeat imaging and consultation to monitor the size of the aneurysm and symptoms.

This proposal is aimed at addressing the urgent need to identify a medical treatment able to limit progression of AAAs.

The study design and rationale are based on strong preclinical evidence supporting the value of eplerenone (an agent indicated for treatment of heart failure) in limiting AAA progression. If proved effective, this medication would:

  1. Reduce the number of patients requiring costly surgery
  2. Reduce the number of surgery related deaths and complications
  3. Provide a therapy suitable for the rapidly expanding elderly age group who have AAAs.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Drug: Eplerenone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eplerenone in the Management of Abdominal Aortic Aneurysms: A Proof-Of-Concept Randomised Controlled Trial
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Eplerenone
25mg Eplerenone once daily for 12 months
Drug: Eplerenone
25mg of eplerenone
Other Name: Inspra

Placebo Comparator: Matching placebo
Matching placebo once daily for 12 months
Drug: Eplerenone
25mg of eplerenone
Other Name: Inspra




Primary Outcome Measures :
  1. abdominal aortic aneurysm maximum orthogonal diameter [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged over 60years (inclusive); AAA measuring a maximum diameter of 30-49 mm on MRI; 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 12 months; stable medication regime for the last six months; have given signed informed consent to participate in the study.

Exclusion Criteria:

  • Serum potassium concentration of more than 5.0 mmol/L before randomisation; evidence of renal impairment defined as serum creatinine>133 umol/L or creatinine clearance of <60 mL/min; known significant renal stenosis (>70%) of one or both renal arteries; evidence of liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function defined as aspartate aminotransferase, alanine aminotransferase or total bilirubin >1.5x the upper limit of normal; evidence of primary aldosteronism (plasma aldosterone/renin ratio>650 pmol/L); electrolyte imbalance; active gout; use of MR antagonists; use of potassium-sparing diuretics, or potassium supplements; individuals with claustrophobia or a history of any metallic prosthetic implant contraindicating MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345590


Contacts
Contact: Leah Isles, MBBS 61 3 90763263 l.iles@alfred.org.au
Contact: Andrew Taylor, MBBS 61 3 90763263 a.taylor@alfred.org.au

Locations
Australia, Victoria
Baker IDI Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Leah Isles, MBBS    61 3 90763263    l.iles@alfred.org.au   
Contact: Andrew Taylor, MBBS    61 3 90763263    a.taylor@alfred.org.au   
Heart Centre, Alfred Health Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Leah Isles, MBBS    61 3 90763263    l.iles@alfred.org.au   
Contact: Andrew Taylor, MBBS    61 3 90763263    a.taylor@alfred.org.au   
Sponsors and Collaborators
Bayside Health
Baker IDI Heart and Diabetes Institute
Investigators
Principal Investigator: Leah Isles, MBBS The Alfred

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT02345590     History of Changes
Other Study ID Numbers: 01/15
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Eplerenone
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents