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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12606000193572 |
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Date of registration:
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24/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Heart Transplant Myocardial Fibrosis Study
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Scientific title:
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Effect of Spironolactone on myocardial fibrosis and myocardial function in patients with left ventricular diastolic dysfunction. |
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Date of first enrolment:
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01/05/2006 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12606000193572.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Phase 4
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Angeline Leet
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Address:
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Heart Centre
The Alfred Hospital
Commercial Rd
Prahran VIC 3181
Australia |
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Telephone:
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+61 3 92766525 |
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Email:
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a.leet@alfred.org.au |
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Affiliation:
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Name:
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Dr Angeline Leet
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Address:
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Heart Centre
The Alfred Hospital
Commercial Rd
Prahran VIC 3181
Australia |
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Telephone:
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+61 3 92766525 |
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Email:
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a.leet@alfred.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: More than 12 months after heart transplantation. Left ventricular diastolic dysfunction, LVEF > 50%.
Exclusion criteria: Allergy to or previous therapy with spironolactone.Abnormal left ventricular systolic function, LVEF < 50% or regional wall motion abnormality.Pregnancy.
Age minimum:
18 Years
Age maximum:
Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Diastolic dysfunction;Myocardial fibrosis after heart transplantation;
Diastolic dysfunction
Myocardial fibrosis after heart transplantation
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Cardiovascular - Other cardiovascular diseases
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Intervention(s)
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Spironolactone 25mg oral, alternate days for one week, target 25mg thereafter for 6 months.
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Primary Outcome(s)
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Myocardial function[After 6 months]
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Secondary Outcome(s)
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Myocardial fibrosis[After 6 months]
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Source(s) of Monetary Support
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Pfizer Cardiovascular Lipid Grant
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Ethics review
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Status: Approved
Approval date:
Contact:
Alfred Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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