Effect of Simvastatin on Cardiac Function
Rheumatic Heart Disease
Congenital Heart Disease
Heart Valve Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial|
- plasma troponin T level [ Time Frame: within the first 7 days after surgery ] [ Designated as safety issue: No ]The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.
- the index of B ultrasound on heart [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]Each patient will be followed up and checked with B ultrasound on heart in 1,3,6 and 12 months after surgery. The index of B ultrasound on heart, such as ejection fraction, the diameter of left ventricle, will be measured
|Study Start Date:||September 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
20 mg per day, start at 5 days before surgery and continue for one year. For some congenital heart diseases which other drugs such as digoxin, antistone, furosemide were prescribed less than half year, simvastatin will be prescribed less than half year.
Other Name: simcor
No Intervention: untreated
Cardiac function is crucial for cardiac surgery. The mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. Thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery.
Although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. However, some results were controversy. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalence.Thus, it is necessary to perform a double blind, randomised clinical trial in China to determine whether statin can protect heart injury during heart surgery in China and what's its mechanism.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178710
|The First Affiliated Hospital, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|
|Principal Investigator:||Jing-song Ou, MD,PhD||The Frist Affiliated Hospital, Sun Yat-sen University|