A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass

What this Trial Is About

Researchers are investigating whether simvastatin, a medication commonly used to lower cholesterol, can protect the heart muscle during noncoronary artery cardiac surgery involving cardiopulmonary bypass and improve heart function when used long term after surgery. Previous findings at a single medical center suggested that simvastatin may reduce heart muscle injury during such surgeries. This study expands the research to two medical centers to further evaluate these effects in patients with congenital heart disease or isolated heart valve disease. Participants are randomly assigned to one of three groups: no treatment, short-term simvastatin, or long-term simvastatin. In the short-term group, simvastatin (20 mg daily) is given for 5 to 7 days before surgery (except on the day of surgery) and then resumed from the second day after surgery for 7 days. In the long-term group, the same preoperative dosing is followed by simvastatin administration for 6 months postoperatively. The control group does not receive simvastatin. During the study, researchers monitor heart muscle injury by measuring troponin levels within the first 7 days after surgery and assess heart function by evaluating ejection fraction up to two years after surgery. Long-term survival is also tracked over two years. Participants undergo regular assessments to monitor these outcomes, and safety is observed throughout the study period. The total follow-up extends to two years post-surgery to evaluate the lasting effects of the treatment.

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery