Effect of Simvastatin on Cardiac Function

Not Applicable

Completed

• Conditions: Rheumatic Heart Disease; Congenital Heart Disease; Aneurysm; Heart Valve Disease
• Interventions: Drug: Simvastatin

• Registration Number: NCT01178710
• Lead Sponsor: Sun Yat-sen University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Study Start: 2010-09
• Primary Completion: 2011-06
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
plasma troponin T level	within the first 7 days after surgery	The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.

Secondary Outcome Measures

Name	Time	Method
the index of B ultrasound on heart	one year after surgery	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

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China