Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000059460
Ethics application status
Approved
Date submitted
9/01/2007
Date registered
18/01/2007
Date last updated
18/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of perhexiline on regional and global cardiac function in patients with viable myocardium
Scientific title
The impact of perhexiline on regional and global cardiac function in post-infarction patients with viable myocardium
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reduced cardiac function in patients with viable myocardium 1553 0
Condition category
Condition code
Cardiovascular 1652 1652 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients are selected following a myocardial infarction. A dobutamine stress echocardiogram is performed to assess suitability (resting wall motion abnormalities with two or more viable segments). All patients then undergo further tests: cardiac magnetic resonance imaging to assess scar thickness, 3-dimensional echo to measure ventricular volumes, and a symptom-limited metabolic exercise test. Patients are randomized to placebo or perhexilene starting at 100 mg/d. Patients are reviewed 7 days after dosing and blood samples are taken for routine biochemistry, full blood count and perhexiline levels. Oral perhexiline or placebo will be introduced at a dose of 100mg bd, and plasma perhexiline levels will be monitored after 7 days’ therapy, with dosage adjustments to achieve steady-state plasma perhexiline concentrations within the therapeutic range of 0.15 to 0.60 micrograms/ml. Patients are reviewed on a regular basis for three months, then six months and at again on completion of the study at 12 months. All cardiac tests will be repeated at 6 and 12 months.
Intervention code [1] 1542 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2280 0
1) Resting function in segments of viable myocardium can be improved with therapy,
Timepoint [1] 2280 0
At 6 months
Primary outcome [2] 2281 0
2) Global left ventricular function can be improved in proportion to the number of viable segments,
Timepoint [2] 2281 0
At 6 months
Primary outcome [3] 2282 0
3) Therapy prevents cardiac remodelling in non-revascularized patients,
Timepoint [3] 2282 0
At 6 months
Primary outcome [4] 2283 0
4) Therapy improves exercise capacity.
Timepoint [4] 2283 0
At 6 months
Primary outcome [5] 2284 0
5) These findings persist at 12 months
Timepoint [5] 2284 0
At 6 months
Secondary outcome [1] 3988 0
1) Metabolic therapy prevents the loss of contractile reserve over 12 months observed in previous studies of viable segments in non-revascularized patients
Timepoint [1] 3988 0
Secondary outcome [2] 3989 0
2) Improvement in dysfunctional segments at 12 months corresponds to changes in insulin sensitivity
Timepoint [2] 3989 0

Eligibility
Key inclusion criteria
Previous myocardial infarction less than a year ago and have more than two viable segments on stress echo.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hemodynamically significant aortic stenosis, planned heart surgery or stenting procedures in the next twelve months, clinically significant liver or kidney disease, or diabetes with frequent episodes of hypoglycaemia. Women who are pregnant or of child bearing age. Implantable defibrillator. Therapy with monoamine oxidase inhibitors.

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 involved contacting the holder of the allocation schedule who was “off-site” or at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, assessor, therapist, data analyst
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1799 0
Charities/Societies/Foundations
Name [1] 1799 0
National Heart Foundation
Country [1] 1799 0
Australia
Primary sponsor type
Individual
Name
Prof T Marwick
Address
Country
Secondary sponsor category [1] 1618 0
None
Name [1] 1618 0
Nil
Address [1] 1618 0
Country [1] 1618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3360 0
Princess Alexandra Hospital Health District PAH
Ethics committee address [1] 3360 0
Ethics committee country [1] 3360 0
Australia
Date submitted for ethics approval [1] 3360 0
Approval date [1] 3360 0
01/03/2005
Ethics approval number [1] 3360 0
2001/043

Summary
Brief summary
Not all of the heart muscle involved in a heart attack is irreversibly damaged. Although bypass operations may lead to improvement in the function of this tissue, the procedure is risky for very many patients who are elderly or sick from other conditions. A number of pieces of evidence suggest that this damaged but viable tissue can be improved by drugs that optimize the use of oxygen in the muscle cells.

We will study patients with damaged heart muscle, using one particular agent (perhexilene) that is produced in Australia. We anticipate that therapy will improve regional and global function of the heart, prevent enlargement and improve exercise capacity, and that these changes will correspond to the effects of the drug on cardiac metabolism. This study is based on particular strengths in measurement of regional and global function and use of cardiac magnetic resonance to improve our understanding of the effect of the amount of scarring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27476 0
Address 27476 0
Country 27476 0
Phone 27476 0
Fax 27476 0
Email 27476 0
Contact person for public queries
Name 10731 0
Ms Helen Branagan
Address 10731 0
Department of Medicine
University of Queensland
Level 4
Princess Alexandra Hospital
Brisbane QLD 4102
Country 10731 0
Australia
Phone 10731 0
+61 7 32406437
Fax 10731 0
+61 7 32405399
Email 10731 0
hbranagan@soms.uq.edu.au
Contact person for scientific queries
Name 1659 0
Professor Tom Marwick
Address 1659 0
Department of Medicine
University of Queensland
Level 4
Princess Alexandra Hospital
Brisbane QLD 4102
Country 1659 0
Australia
Phone 1659 0
+61 7 32405340
Fax 1659 0
+61 7 32405399
Email 1659 0
t.marwick@uq.edu.au

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.