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Effect of Simvastatin on Cardiac Function

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Aneurysm
Rheumatic Heart Disease
Congenital Heart Disease
Heart Valve Disease

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01178710
statinstudy1

Details and patient eligibility

About

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.

Full 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.

Enrollment

151 patients

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

151 participants in 2 patient groups

treatment
Experimental group
Treatment:
Drug: Simvastatin
untreated
No Intervention group
Description:
control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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