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NCT Number: NCT01653223

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Disease Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Cong-zhi Rao, MD

CONTACT

[email protected]

87333122

Jing-song Ou, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

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

Primary outcomes

  1. troponin

    Time frame: within the first 7 days after surgery

    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.

  2. ejection fraction

    Time frame: within two years

    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 outcomes

  1. long term survival

    Time frame: within two years

    Each patient will be followed up and observed survival time.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing-song Ou, MD, PhD

CONTACT

[email protected]

8620-87755766 ext. 8238

Zhi-ping Wang, MD, PhD

CONTACT

8620-87755766 ext. 8238

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2024
Study completion
2026
First posted
Jul 30, 2012
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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