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Effect of Simvastatin on Cardiac Function

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatic Heart Disease; Congenital Heart Disease; Aneurysm; Heart Valve Disease

Intervention: Simvastatin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Jing-song Ou, MD,PhD, Principal Investigator, Affiliation: The Frist Affiliated Hospital, Sun Yat-sen University

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.

Clinical Details

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

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

Primary outcome: plasma troponin T level

Secondary outcome: the index of B ultrasound on heart

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.

Eligibility

Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, China
Additional Information

Starting date: September 2010
Last updated: July 25, 2012

Page last updated: August 23, 2015

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