Clinical Trial: Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy

Brief 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.


Detailed Summary:
Sponsor: University Hospital Birmingham

Current Primary Outcome: Absolute difference in Cardiac Index (>0.3 l/min/m2) [ Time Frame: 6 hours post-removal of aortic X-clamp ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Low Cardiac Output Syndrome [ Time Frame: 6 hours post-removal of aortic X-clamp ]
  • Incidence of inotrope use according to protocol [ Time Frame: 6 and 12 hours post-removal of aortic X-clamp ]
  • Peak and total release of Troponin [ Time Frame: 12 and 24 hours post-release of aortic X-clamp ]


Original Secondary Outcome: Same as current

Information By: University Hospital Birmingham

Dates:
Date Received: October 2, 2009
Date Started: October 2009
Date Completion: December 2012
Last Updated: August 10, 2011
Last Verified: April 2011