Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01653223

Enrollment

369

Registered

2012-07-30

Start date

2013-01-31

Completion date

2026-12-31

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Heart Valve Disease

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.

Interventions

DRUGsimvastatin

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
long term survival	within two years	Each patient will be followed up and observed survival time.

Countries

China

Contacts

Primary ContactJing-song Ou, MD, PhD

oujs2000@yahoo.com8620-87755766

Backup ContactZhi-ping Wang, MD, PhD

8620-87755766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026