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Eplerenone in the Management of Abdominal Aortic Aneurysms

NCT02345590 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2016-01-15

No results posted yet for this study

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.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DRUG

Eplerenone

25mg of eplerenone

Sponsors & Collaborators

  • Baker Heart and Diabetes Institute

    collaborator OTHER

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Leah Isles, MBBS · The Alfred

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345590 on ClinicalTrials.gov