Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
151 participants
INTERVENTIONAL
2010-09-30
2012-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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treatment
Simvastatin
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.
untreated
control
No interventions assigned to this group
Interventions
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Simvastatin
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* noncyanotic congenital heart disease with pulmonary hypertension
* Heart valve disease,
* other heart and great artery diseases need heart or great artery surgery
Exclusion Criteria
* under 10-year-old.
* noncyanotic congenital heart disease without pulmonary hypertension
* poor liver function such AST elevated,Hepatitis
* Gestation women and Breast-feeding women
10 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Jing-song Ou
associate chief
Principal Investigators
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Jing-song Ou, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Frist Affiliated Hospital, Sun Yat-sen University
Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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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 on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial. Circulation. 2001 Nov 27;104(22):2660-5. doi: 10.1161/hc4701.099730.
Ali IS, Buth KJ. Preoperative statin use and outcomes following cardiac surgery. Int J Cardiol. 2005 Aug 3;103(1):12-8. doi: 10.1016/j.ijcard.2004.06.006. Epub 2004 Nov 6.
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. doi: 10.1152/ajpheart.00347.2006. Epub 2006 Jul 14.
Almansob MA, Xu B, Zhou L, Hu XX, Chen W, Chang FJ, Ci HB, Yao JP, Xu YQ, Yao FJ, Liu DH, Zhang WB, Tang BY, Wang ZP, Ou JS. Simvastatin reduces myocardial injury undergoing noncoronary artery cardiac surgery: a randomized controlled trial. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2304-13. doi: 10.1161/ATVBAHA.112.252098. Epub 2012 Jul 12.
Related Links
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Related Info
Other Identifiers
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statinstudy1
Identifier Type: -
Identifier Source: org_study_id