Effect of Simvastatin on Cardiac Function
Information source: Sun Yat-sen University
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Recruiting
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
Overall contact:
Jing-song Ou, MD, PhD, Phone: 8620-87755766, Ext: 8238, Email: oujs2000@yahoo.com
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
Jing-song Ou, MD, PhD, Phone: 8620-87755766, Ext: 8238, Email: oujs2000@yahoo.com
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, China; Recruiting
Cong-zhi Rao, MD,PhD, Phone: 87333122, Email: raoczh@mail.sysu.edu.cn
Jing-song Ou, MD,PhD, Principal Investigator
Additional Information
Starting date: September 2010
Last updated: July 20, 2011
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