Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease; Heart Valve Disease
• Interventions: Drug: simvastatin

• Registration Number: NCT01653223
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-30
• Study Start: 2013-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 369

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short statin	simvastatin	Simvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 7 days postoperatively.
long statin	simvastatin	Simvastatin (20 mg) was administered every day for the 5-7 days preoperatively, but not the day of surgery in the statin group. Then simvastatin was re-administered at the second day until 6 months postoperatively.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
long term survival	within two years	Each patient will be followed up and observed survival time.

Trial Locations

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China