Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Congenital Heart Disease Clinical Trial

Official title:

A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01653223
• Other study ID #: statin2
• Secondary ID: 5010-20120015010
• Status: Recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2026

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Jing-song Ou, MD, PhD
• Phone: 8620-87755766
• Email: oujs2000[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 369
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Valve Disease
• Heart Valve Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	troponin	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.	within the first 7 days after surgery
Primary	ejection fraction	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.	within two years
Secondary	long term survival	Each patient will be followed up and observed survival time.	within two years