Effect of Simvastatin on Cardiac Function
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatic Heart Disease Congenital Heart Disease Aneurysm Heart Valve Disease |
Drug: Simvastatin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial |
- plasma troponin T level [ Time Frame: within the first 7 days after surgery ] [ Designated as safety issue: No ]The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.
- the index of B ultrasound on heart [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]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
| Enrollment: | 151 |
| Study Start Date: | September 2010 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: treatment |
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.
Other Name: simcor
|
|
No Intervention: untreated
control
|
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| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Guangdong | |
| The First Affiliated Hospital, Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510080 | |
| Principal Investigator: | Jing-song Ou, MD,PhD | The Frist Affiliated Hospital, Sun Yat-sen University |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jing-song Ou, associate chief, Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT01178710 History of Changes |
| Other Study ID Numbers: | statinstudy1 |
| Study First Received: | August 9, 2010 |
| Last Updated: | July 25, 2012 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Aneurysm Heart Diseases Heart Valve Diseases Rheumatic Diseases Rheumatic Heart Disease Heart Defects, Congenital Vascular Diseases Cardiovascular Diseases Musculoskeletal Diseases Connective Tissue Diseases Rheumatic Fever Streptococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Cardiovascular Abnormalities Congenital Abnormalities Simvastatin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013