NCT00845364

Metabolic Support With Perhexiline to Protect Myocardium Undergoing Coronary Artery Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: University Hospital Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Myocardial Reperfusion Injury
• Cardiac Output, Low

Interventions

Type	Name	Description
DRUG	Perhexiline	Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.
DRUG	Placebo marked PEXSIG	Tablets. Dose: 200mg BD for 3 days, then 100mg BD until surgery. Duration of therapy: 5-31 days.

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-02-18
• Last updated: 2010-05-20

Locations

2 sites across 1 country: United Kingdom