Effect of Simvastatin on Cardiac Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jing-song Ou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01178710
First received: August 9, 2010
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Rheumatic Heart Disease
Congenital Heart Disease
Aneurysm
Heart Valve Disease
Drug: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Cardiac Protective Effect of Simvastatin on Cardiac Surgery: a Double Blind, Randomised Clinical Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • plasma troponin T level [ Time Frame: within the first 7 days after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]
    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


Enrollment: 151
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment Drug: Simvastatin
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.
Other Name: simcor
No Intervention: untreated
control

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01178710

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jing-song Ou, associate chief, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01178710     History of Changes
Other Study ID Numbers: statinstudy1
Study First Received: August 9, 2010
Last Updated: July 25, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Rheumatic Fever
Aneurysm
Heart Diseases
Heart Valve Diseases
Rheumatic Diseases
Rheumatic Heart Disease
Heart Defects, Congenital
Vascular Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
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 28, 2014