Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Jing-song Ou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01653223
First received: July 26, 2012
Last updated: July 12, 2014
Last verified: July 2014
  Purpose

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. We recent found simvastatin reduced myocardial injury during noncoronary artery cardiac surgery in single medical center. We 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.


Condition Intervention
Congenital Heart Disease
Heart Valve Disease
Drug: simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Study of Simvastatin on Myocardial Protection and Cardiac Function Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • troponin [ Time Frame: within the first 7 days after surgery ] [ Designated as safety issue: Yes ]
    The investigator will measure the plasma troponin level in several time points before and after surgery in each patient.


Secondary Outcome Measures:
  • ejection fraction [ Time Frame: within two years ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • long term survival [ Time Frame: within two years ] [ Designated as safety issue: No ]
    Each patient will be followed up and observed survival time.


Estimated Enrollment: 369
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: simcor

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Hypercholesterolemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653223

Contacts
Contact: Jing-song Ou, MD, PhD 8620-87755766 ext 8238 oujs2000@yahoo.com
Contact: Zhi-ping Wang, MD, PhD 8620-87755766 ext 8238

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Cong-zhi Rao, MD    87333122    raoczh@mail.sysu.edu.cn   
Principal Investigator: Jing-song Ou, MD,PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Jing-song Ou, MD,PhD The Frist Affiliated Hospital, Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Jing-song Ou, associate chief, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01653223     History of Changes
Other Study ID Numbers: statin2, 5010-2012001
Study First Received: July 26, 2012
Last Updated: July 12, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014