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Effect of Simvastatin on Cardiac Function

Primary Purpose

Rheumatic Heart Disease, Congenital Heart Disease, Aneurysm

Status
Completed
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 Rheumatic Heart Disease

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cyanotic congenital heart disease
  • noncyanotic congenital heart disease with pulmonary hypertension
  • Heart valve disease,
  • other heart and great artery diseases need heart or great artery surgery

Exclusion Criteria:

  • Coronary artery disease
  • under 10-year-old.
  • noncyanotic congenital heart disease without pulmonary hypertension
  • poor liver function such AST elevated,Hepatitis
  • Gestation women and Breast-feeding women

Sites / Locations

  • The First Affiliated Hospital, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment

untreated

Arm Description

control

Outcomes

Primary Outcome Measures

plasma troponin T level
The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.

Secondary Outcome Measures

the index of B ultrasound on heart
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6 and 12 months after surgery. The index of B ultrasound on heart, such as ejection fraction, the diameter of left ventricle, will be measured

Full Information

First Posted
August 9, 2010
Last Updated
July 25, 2012
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01178710
Brief Title
Effect of Simvastatin on Cardiac Function
Official Title
The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2012 (Actual)

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
It is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. It was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. However, some results were controversial. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalent. Thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in Chinese. Part of patients will receive statin treatment and part of will not before surgery in the study. Both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.
Detailed Description
Cardiac function is crucial for cardiac surgery. The mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. Thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery. Although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. However, some results were controversy. Also, there is no clinical data available on statin cardiac protection during surgery in China where rheumatic heart disease is prevalence.Thus, it is necessary to perform a double blind, randomised clinical trial in China to determine whether statin can protect heart injury during heart surgery in China and what's its mechanism.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Title
untreated
Arm Type
No Intervention
Arm Description
control
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
simcor
Intervention Description
20 mg per day, start at 5 days before surgery and continue for one year. For some congenital heart diseases which other drugs such as digoxin, antistone, furosemide were prescribed less than half year, simvastatin will be prescribed less than half year.
Primary Outcome Measure Information:
Title
plasma troponin T level
Description
The investigator will measure the plasma troponin T level in several time points before and after surgery in each patient.
Time Frame
within the first 7 days after surgery
Secondary Outcome Measure Information:
Title
the index of B ultrasound on heart
Description
Each patient will be followed up and checked with B ultrasound on heart in 1,3,6 and 12 months after surgery. The index of B ultrasound on heart, such as ejection fraction, the diameter of left ventricle, will be measured
Time Frame
one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cyanotic congenital heart disease noncyanotic congenital heart disease with pulmonary hypertension Heart valve disease, other heart and great artery diseases need heart or great artery surgery Exclusion Criteria: Coronary artery disease under 10-year-old. noncyanotic congenital heart disease without pulmonary hypertension poor liver function such AST elevated,Hepatitis Gestation women and Breast-feeding women
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
11723015
Citation
White CW, Gobel FL, Campeau L, Knatterud GL, Forman SA, Forrester JS, Geller NL, Herd JA, Hickey A, Hoogwerf BJ, Hunninghake DB, Rosenberg Y, Terrin ML; Post Coronary Artery Bypass Graft Trial Investigators. Effect of an aggressive lipid-lowering strategy on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial. Circulation. 2001 Nov 27;104(22):2660-5. doi: 10.1161/hc4701.099730.
Results Reference
result
PubMed Identifier
16061117
Citation
Ali IS, Buth KJ. Preoperative statin use and outcomes following cardiac surgery. Int J Cardiol. 2005 Aug 3;103(1):12-8. doi: 10.1016/j.ijcard.2004.06.006. Epub 2004 Nov 6.
Results Reference
result
PubMed Identifier
16844920
Citation
Greer JJ, Kakkar AK, Elrod JW, Watson LJ, Jones SP, Lefer DJ. Low-dose simvastatin improves survival and ventricular function via eNOS in congestive heart failure. Am J Physiol Heart Circ Physiol. 2006 Dec;291(6):H2743-51. doi: 10.1152/ajpheart.00347.2006. Epub 2006 Jul 14.
Results Reference
result
PubMed Identifier
22796581
Citation
Almansob MA, Xu B, Zhou L, Hu XX, Chen W, Chang FJ, Ci HB, Yao JP, Xu YQ, Yao FJ, Liu DH, Zhang WB, Tang BY, Wang ZP, Ou JS. Simvastatin reduces myocardial injury undergoing noncoronary artery cardiac surgery: a randomized controlled trial. Arterioscler Thromb Vasc Biol. 2012 Sep;32(9):2304-13. doi: 10.1161/ATVBAHA.112.252098. Epub 2012 Jul 12.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/
Description
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Effect of Simvastatin on Cardiac Function

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