Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Sun Yat-sen University

Status: Enrolling

Conditions: Congenital Heart Disease; Heart Valve Disease

Treatments: Drug: simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01653223

5010-2014002 (Other Grant/Funding Number)

5010-2012001 (Other Grant/Funding Number)

statin2

Details and patient eligibility

About

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.

Enrollment: 369 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

369 participants in 3 patient groups

control

No Intervention group

Description:

untreated

short statin

Experimental group

Description:

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.

Treatment:

Drug: simvastatin

long statin

Experimental group

Description:

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.

Treatment:

Drug: simvastatin