Eplerenone in the Management of Abdominal Aortic Aneurysms
Information source: Bayside Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aortic Aneurysm, Abdominal
Intervention: Eplerenone (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Bayside Health
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.
Clinical Details
Official title: Eplerenone in the Management of Abdominal Aortic Aneurysms: A Proof-Of-Concept Randomised Controlled Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: abdominal aortic aneurysm maximum orthogonal diameter
Eligibility
Minimum age: 60 Years.
Maximum age: 90 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: April 2015
Last updated: January 19, 2015
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