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NCT Number: NCT01178710

Effect of Simvastatin on Cardiac Function

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.

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Key information

Conditions

Rheumatic Heart Disease Aneurysm Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gram-Positive Bacterial Infections Heart Defects, Congenital Heart Diseases Heart Valve Disease Heart Valve Diseases Infections Rheumatic Fever Streptococcal Infections Vascular Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

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 names: simcor

Primary outcomes

  1. plasma troponin T level

    Time frame: 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 outcomes

  1. the index of B ultrasound on heart

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 10, 2010
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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