Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000065796
Ethics application status
Approved
Date submitted
20/12/2012
Date registered
17/01/2013
Date last updated
13/08/2019
Date data sharing statement initially provided
13/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of aldosterone blockade in hypertrophic cardiomyopathy
Scientific title
Anti-fibrotic role of eplerenone on diffuse myocardial fibrosis and diastolic function in patients with hypertrophic cardiomyopathy
Secondary ID [1] 281704 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertrophic cardiomyopathy 287997 0
Condition category
Condition code
Cardiovascular 288377 288377 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eplerenone 50mg orally once daily for 12 months
Intervention code [1] 286240 0
Treatment: Drugs
Comparator / control treatment
Placebo (identical to eplerenone 50mg orally once daily for 12 months but without the active ingredient)
Control group
Placebo

Outcomes
Primary outcome [1] 288548 0
Difference in quantification of diffuse myocardial fibrosis as assessed with cardiac magnetic resonance imaging
Timepoint [1] 288548 0
12 months after commencement of eplerenone or placebo
Secondary outcome [1] 300439 0
Difference in diastolic function as assessed with echocardiography
Timepoint [1] 300439 0
12 months after commencement of eplerenone or placebo
Secondary outcome [2] 300440 0
Functional status as assessed by New York Heart Association (NYHA) class and V02 max test.
Timepoint [2] 300440 0
12 months after commencement of eplerenone or placebo

Eligibility
Key inclusion criteria
Confirmed diagnosis of hypertrophic cardiomyopathy
Ability to swallow pills
Not pregnant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contra-indication to cardiac MRI, including administration of gadolinium-based IV contrast
Co-existing cardiac condition with may contribute to myocardial fibrosis
Unable to take aldosterone antagonist

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/03/2013
Actual
25/06/2016
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
80
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286493 0
Government body
Name [1] 286493 0
NHMRC
Country [1] 286493 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Taylor
Address
Heart Centre
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 285283 0
Individual
Name [1] 285283 0
Dr Leah Iles
Address [1] 285283 0
Heart Centre
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Country [1] 285283 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288571 0
Alfred Hospital Research and Ethics Unit
Ethics committee address [1] 288571 0
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Ethics committee country [1] 288571 0
Australia
Date submitted for ethics approval [1] 288571 0
28/01/2013
Approval date [1] 288571 0
24/04/2015
Ethics approval number [1] 288571 0

Summary
Brief summary
The hypothesis to be tested is that diffuse fibrosis in patients with hypertrophic cardiomyopathy is reduced following eplerenone therapy in a randomised, double-blind placebo controlled study
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36722 0
Dr Andrew Taylor
Address 36722 0
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Country 36722 0
Australia
Phone 36722 0
+61 3 9076 3263
Fax 36722 0
Email 36722 0
a.taylor@alfred.org.au
Contact person for public queries
Name 36723 0
Dr Andrew Taylor
Address 36723 0
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Country 36723 0
Australia
Phone 36723 0
+61 3 9076 3263
Fax 36723 0
Email 36723 0
a.taylor@alfred.org.au
Contact person for scientific queries
Name 36724 0
Dr Andrew Taylor
Address 36724 0
The Alfred Hospital
55 Commercial Road
Melbourne, Victoria 3004
Country 36724 0
Australia
Phone 36724 0
+61 3 9076 3263
Fax 36724 0
Email 36724 0
a.taylor@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.