Effect of Simvastatin on Cardiac Function

Congenital Heart Disease Clinical Trial

Official title:

The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178710
• Other study ID #: statinstudy1
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: July 25, 2012
• Start date: September 2010
• Est. completion date: July 2012

Study information

• 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

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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

External Links

•   Link