Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Heart Valve Disease
• Intervention / Treatment: Drug: simvastatin

• Study Type: Interventional
• Enrollment (Anticipated): 369
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing-song Ou, MD, PhD; Phone Number: 8238 8620-87755766; Email: oujs2000@yahoo.com
• Study Contact Backup: Name: Zhi-ping Wang, MD, PhD; Phone Number: 8238 8620-87755766

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital, Sun Yat-Sen University
      • Contact: Cong-zhi Rao, MD; Phone Number: 87333122; Email: raoczh@mail.sysu.edu.cn
      • Principal Investigator: Jing-song Ou, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; untreated
Experimental: short statin; 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.	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.; Other Names: simcor
Experimental: long statin; 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.	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.; Other Names: simcor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 30, 2012

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Heart Valve Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: statin2; 5010-2012001 (Other Grant/Funding Number: Sun Yat-sen University); 5010-2014002 (Other Grant/Funding Number: Sun Yat-sen University)