NCT02345590

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

3.6 years

First QC Date

January 11, 2015

Last Update Submit

January 13, 2016

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (1)

  • abdominal aortic aneurysm maximum orthogonal diameter

    12 months

Study Arms (2)

Eplerenone

EXPERIMENTAL

25mg Eplerenone once daily for 12 months

Drug: Eplerenone

Matching placebo

PLACEBO COMPARATOR

Matching placebo once daily for 12 months

Drug: Eplerenone

Interventions

EplerenoneDRUG

25mg of eplerenone

Also known as: Inspra
EplerenoneMatching placebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baker IDI

Melbourne, Victoria, 3000, Australia

RECRUITING

Heart Centre, Alfred Health

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Leah Isles, MBBS

    The Alfred

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Isles, MBBS

CONTACT

61 3 90763263l.iles@alfred.org.au

Andrew Taylor, MBBS

CONTACT

61 3 90763263a.taylor@alfred.org.au

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2015

First Posted

January 26, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

AU(2)