Effect of Simvastatin on Cardiac Function

NCT01178710 | Completed DMC

• 1 other identifier: statinstudy1
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatic Heart Disease; Congenital Heart Disease; Aneurysm; Heart Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the index of B ultrasound on heart

  one year after surgery

Study Arms (2)

treatment

EXPERIMENTAL

Drug: Simvastatin

untreated

NO INTERVENTION

control

Interventions

Simvastatin DRUG

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.

Also known as: simcor

treatment

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (4)

• 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.

  PMID: 11723015 RESULT

• 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.

  PMID: 16061117 RESULT

• 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.

  PMID: 16844920 RESULT

• 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.

  PMID: 22796581 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Rheumatic Heart Disease; Heart Defects, Congenital; Aneurysm; Heart Valve Diseases

Interventions

Simvastatin; Simcor

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jing-song Ou, MD,PhD

  The Frist Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 10, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

CN (1)