Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-heart surgery causes injury of the heart muscle. Although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. During surgery, techniques are used to protect the heart from injury, but these remain imperfect. Patients with a thickened wall of the heart (left ventricular hypertrophy) may be at greater risk. This study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug Perhexiline given before the operation.

This treatment has a sound experimental basis for improving outcome. If this improvement is confirmed surgical results could be improved. The investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. The investigators' hypothesis is that Perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham
• Collaborators: Brighton and Sussex University Hospitals NHS Trust; British Heart Foundation; University of Birmingham
• Treatments: Perhexiline

Criteria

Inclusion Criteria:

• Adult

• First-time

• Aortic valve surgery for aortic stenosis +/- coronary artery bypass

Exclusion Criteria:

• Diabetes Mellitus

• Renal impairment with Creatinine greater than or equal to 200micromol/L

• Atrial fibrillation

• Amiodarone therapy, recent (in last month) or current

• Hepatic impairment, significant preoperative

• Peripheral neuropathy

• Pregnancy or breast-feeding

• Emergency surgery or required on clinical grounds within 5 days of referral