Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02345590




Registration number
NCT02345590
Ethics application status
Date submitted
11/01/2015
Date registered
26/01/2015
Date last updated
15/01/2016

Titles & IDs
Public title
Eplerenone in the Management of Abdominal Aortic Aneurysms
Scientific title
Eplerenone in the Management of Abdominal Aortic Aneurysms: A Proof-Of-Concept Randomised Controlled Trial
Secondary ID [1] 0 0
01/15
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysm, Abdominal 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eplerenone

Experimental: Eplerenone - 25mg Eplerenone once daily for 12 months

Placebo Comparator: Matching placebo - Matching placebo once daily for 12 months


Treatment: Drugs: Eplerenone
25mg of eplerenone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
abdominal aortic aneurysm maximum orthogonal diameter
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
172
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker IDI - Melbourne
Recruitment hospital [2] 0 0
Heart Centre, Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart and Diabetes Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02345590
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leah Isles, MBBS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Leah Isles, MBBS
Address 0 0
Country 0 0
Phone 0 0
61 3 90763263
Fax 0 0
Email 0 0
l.iles@alfred.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02345590