Congenital Heart Disease Clinical Trial
Official title:
The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
Verified date | July 2012 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.
Status | Completed |
Enrollment | 151 |
Est. completion date | July 2012 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - cyanotic congenital heart disease - noncyanotic congenital heart disease with pulmonary hypertension - Heart valve disease, - other heart and great artery diseases need heart or great artery surgery Exclusion Criteria: - Coronary artery disease - under 10-year-old. - noncyanotic congenital heart disease without pulmonary hypertension - poor liver function such AST elevated,Hepatitis - Gestation women and Breast-feeding women |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Ali IS, Buth KJ. Preoperative statin use and outcomes following cardiac surgery. Int J Cardiol. 2005 Aug 3;103(1):12-8. Epub 2004 Nov 6. — View Citation
Greer JJ, Kakkar AK, Elrod JW, Watson LJ, Jones SP, Lefer DJ. Low-dose simvastatin improves survival and ventricular function via eNOS in congestive heart failure. Am J Physiol Heart Circ Physiol. 2006 Dec;291(6):H2743-51. Epub 2006 Jul 14. — View Citation
White CW, Gobel FL, Campeau L, Knatterud GL, Forman SA, Forrester JS, Geller NL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Rosenberg Y, Terrin ML; Post Coronary Artery Bypass Graft Trial Investigators. Effect of an aggressive lipid-lowering strategy — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plasma troponin T level | The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient. | within the first 7 days after surgery | No |
Secondary | the index of B ultrasound on heart | 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 | one year after surgery | No |
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