Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000193572
Ethics application status
Approved
Date submitted
23/03/2006
Date registered
24/05/2006
Date last updated
24/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Heart Transplant Myocardial Fibrosis Study
Scientific title
Effect of Spironolactone on myocardial fibrosis and myocardial function in patients with left ventricular diastolic dysfunction.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diastolic dysfunction 1168 0
Myocardial fibrosis after heart transplantation 1169 0
Condition category
Condition code
Cardiovascular 1253 1253 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spironolactone 25mg oral, alternate days for one week, target 25mg thereafter for 6 months.
Intervention code [1] 953 0
None
Comparator / control treatment
Placebo one tablet alternate day for one week then target one tablet daily for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 1691 0
Myocardial function
Timepoint [1] 1691 0
After 6 months
Secondary outcome [1] 3033 0
Myocardial fibrosis
Timepoint [1] 3033 0
After 6 months

Eligibility
Key inclusion criteria
More than 12 months after heart transplantation. Left ventricular diastolic dysfunction, LVEF > 50%.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to or previous therapy with spironolactone.Abnormal left ventricular systolic function, LVEF < 50% or regional wall motion abnormality.Pregnancy.

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)
Allocation by holder of the allocation schedule who is in pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1367 0
Commercial sector/Industry
Name [1] 1367 0
Pfizer Cardiovascular Lipid Grant
Country [1] 1367 0
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 1207 0
None
Name [1] 1207 0
Nil
Address [1] 1207 0
Country [1] 1207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2723 0
Alfred Hospital
Ethics committee address [1] 2723 0
Ethics committee country [1] 2723 0
Australia
Date submitted for ethics approval [1] 2723 0
Approval date [1] 2723 0
03/05/2006
Ethics approval number [1] 2723 0
56/06

Summary
Brief summary
Primary purpose of the trial is to assess the effect of spironolactone on improving heart function, and its ability to reduce the amount of fibrosis (scar tissue) in the transplant heart of patients who have evidence of stiff hearts and therefore likely have increased scar tissue in the hearts.

The investigators including cardiologists seeing the participants in the outpatient clinic and performing the cardiac biopsies and coronary sinus blood sampling, nursing staff involved in the heart transplant outpatient clinic, the cardiologists reporting on the Echocardiograms and Cardiac MRI; and the pathologists reporting on the blood investigations will be blinded to the treatment arm that the patient has been randomized into. The research study pharmacist will be performing the randomization from the Pharmacy department at The Alfred Hospital, and records of patient randomization will be stored in a sealed envelope for the duration of the patient's involvement in the trial, but accessible in case it becomes medically necessary (eg for adverse effects) to withdraw the patient from the trial and unblind them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36021 0
Address 36021 0
Country 36021 0
Phone 36021 0
Fax 36021 0
Email 36021 0
Contact person for public queries
Name 10142 0
Dr Angeline Leet
Address 10142 0
Heart Centre
The Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 10142 0
Australia
Phone 10142 0
+61 3 92766525
Fax 10142 0
+61 3 92762461
Email 10142 0
[email protected]
Contact person for scientific queries
Name 1070 0
Dr Angeline Leet
Address 1070 0
Heart Centre
The Alfred Hospital
Commercial Rd
Prahran VIC 3181
Country 1070 0
Australia
Phone 1070 0
+61 3 92766525
Fax 1070 0
+61 3 92762461
Email 1070 0
[email protected]

No information has been provided regarding IPD availability


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.