RecruitingACTRN12607000059460

The impact of perhexiline on regional and global cardiac function in patients with viable myocardium

The impact of perhexiline on regional and global cardiac function in post-infarction patients with viable myocardium

Sponsor

Prof T Marwick

Enrollment

100 participants

Start Date

Apr 5, 2005

Study Type

Interventional

Conditions

Reduced cardiac function in patients with viable myocardium

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who have had a heart attack and have heart muscle that is damaged but may still be alive (called 'viable myocardium'). The study tests whether a medication called perhexiline — which helps heart muscle use energy more efficiently — can improve heart function, prevent the heart from getting bigger (enlarging), and improve exercise ability. Heart function will be measured using ultrasound and MRI scans of the heart before and after treatment. You may be eligible if: - You are 18 years of age or older - You had a heart attack less than one year ago - You have more than two areas of viable (salvageable) heart muscle on a stress echo test You may NOT be eligible if: - You have a significant narrowing of the aortic valve - You are planning to have heart surgery or a stenting procedure in the next 12 months - You have significant liver or kidney disease - You have diabetes with frequent low blood sugar episodes - You are a woman who is pregnant or could become pregnant - You have an implantable defibrillator - You are taking MAO inhibitor medications Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.

Locations(1)

Australia

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ACTRN12607000059460