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Eplerenone in the Management of Abdominal Aortic Aneurysms

Primary Purpose

Aortic Aneurysm, Abdominal

Status
Unknown status
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
Bayside Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Abdominal

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baker IDIRecruiting
  • Heart Centre, Alfred HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eplerenone

Matching placebo

Arm Description

25mg Eplerenone once daily for 12 months

Matching placebo once daily for 12 months

Outcomes

Primary Outcome Measures

abdominal aortic aneurysm maximum orthogonal diameter

Secondary Outcome Measures

Full Information

First Posted
January 11, 2015
Last Updated
January 13, 2016
Sponsor
Bayside Health
Collaborators
Baker Heart and Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02345590
Brief Title
Eplerenone in the Management of Abdominal Aortic Aneurysms
Official Title
Eplerenone in the Management of Abdominal Aortic Aneurysms: A Proof-Of-Concept Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
Baker Heart and Diabetes Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone
Arm Type
Experimental
Arm Description
25mg Eplerenone once daily for 12 months
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Inspra
Intervention Description
25mg of eplerenone
Primary Outcome Measure Information:
Title
abdominal aortic aneurysm maximum orthogonal diameter
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Isles, MBBS
Phone
61 3 90763263
Email
l.iles@alfred.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Taylor, MBBS
Phone
61 3 90763263
Email
a.taylor@alfred.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Isles, MBBS
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker IDI
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Isles, MBBS
Phone
61 3 90763263
Email
l.iles@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Andrew Taylor, MBBS
Phone
61 3 90763263
Email
a.taylor@alfred.org.au
Facility Name
Heart Centre, Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Isles, MBBS
Phone
61 3 90763263
Email
l.iles@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Andrew Taylor, MBBS
Phone
61 3 90763263
Email
a.taylor@alfred.org.au

12. IPD Sharing Statement

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Eplerenone in the Management of Abdominal Aortic Aneurysms

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