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Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Primary Purpose

Congenital Heart Disease, Heart Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
simvastatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control

short statin

long statin

Arm Description

untreated

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

long term survival
Each patient will be followed up and observed survival time.

Full Information

First Posted
July 26, 2012
Last Updated
April 19, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01653223
Brief Title
Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery
Official Title
A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Heart Valve Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
369 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
untreated
Arm Title
short statin
Arm Type
Experimental
Arm 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.
Arm Title
long statin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
simvastatin
Other Intervention Name(s)
simcor
Intervention Description
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.
Primary Outcome Measure Information:
Title
troponin
Description
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.
Time Frame
within the first 7 days after surgery
Title
ejection fraction
Description
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.
Time Frame
within two years
Secondary Outcome Measure Information:
Title
long term survival
Description
Each patient will be followed up and observed survival time.
Time Frame
within two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-song Ou, MD, PhD
Phone
8620-87755766
Ext
8238
Email
oujs2000@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-ping Wang, MD, PhD
Phone
8620-87755766
Ext
8238
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-song Ou, MD,PhD
Organizational Affiliation
The Frist Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cong-zhi Rao, MD
Phone
87333122
Email
raoczh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jing-song Ou, MD,PhD

12. IPD Sharing Statement

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Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

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