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Recruiting Not applicable

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

NCT01653223 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2013-01
Last updated
2023-04-21

Condition(s) studied

Congenital Heart DiseaseHeart Valve Disease

Investigational drug(s) / intervention(s)

simvastatin →

simvastatin: In short statin group: 20 mg per day, start at 5-7 days before surgery and continue for 7 days. In long statin group: 20 mg per day, start at 5-7 days before surgery and continue for 6 months.

Study summary

Statins have been used to low cholesterol to prevent and treat coronary artery diseases. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. The investigators recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. The investigators further investigate that whether simvastatin can protect myocardium during noncoronary artery cardiac surgery with cardiopulmonary bypass and improve cardiac function with long term use postoperatively in two medical centers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * More than 18-year-old, * Congenital heart disease(not complex), * Isolated heart valve disease, Exclusion Criteria: * Coronary artery disease * Allergy for statins * Poor liver function,Hepatitis * Gestation women and Breast-feeding women

Primary outcome measure(s)

  • troponin — within the first 7 days after surgery
    The investigator will measure the plasma troponin level in several time points before and after surgery in each patient. This is mainly for the comparason between control and short statin, which has been proved in our previous clinical trial: statin1.
  • ejection fraction — within two years
    Each patient will be followed up and checked with B ultrasound on heart in 1,3,6,12,18 and 24 months after surgery. The ejection fraction will be measured. This is mainly for the comparason between short statin and long statin, which is the major goal in this clinical trial: statin 2.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01653223 on ClinicalTrials.gov ↗ ← All trials in China