A Trial to Evaluate the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery

A Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Effect of Rosuvastatin on Inflammation in Patients Undergoing Isolated Cardiac Valve Surgery

High-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.

Inclusion Criteria:

• Single or multiple valve repairs or replacements without coronary artery bypass grafting
• Bentall procedure, but no other aortic procedures
• With or without accompanying MAZE procedure (surgical treatment for atrial fibrillation)

Exclusion Criteria:

• Age under 18 years old
• Urgent or emergency surgery
• Unable to provide consent
• Presently on statin therapy or exposure to statins within a month of surgery
• Chronic anti-inflammatory use, including steroids and NSAID's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period)
• Known hypersensitivity to rosuvastatin
• Active liver disease Indicated by AST/ALT higher than 3 times the upper limit of normal
• Pregnant or nursing women
• On drugs with interactions (Cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) Severe renal impairment not on dialysis
• Creatinine clearance < 30 ml/min/1.73 m2
• Known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease)
• Human Immunodeficiency Virus