None listed
Conditions
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.
Interventions
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 af
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.
Sponsors
Prof T Marwick
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Previous myocardial infarction less than a year ago and have more than two viable segments on stress echo.
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.
Outcome results
None listed