Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients

NCT ID: NCT07089589

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6006 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-02
• Study Completion Date: 2025-05-19

Brief Summary

The goal of this observational study is to determine whether preoperative statin use reduces major adverse cardiovascular events or other complications after liver transplantation. The main question it aims to answer is:

Does preoperative statin use reduce major adverse cardiovascular events or other complications after liver transplantation? The records of participants who already took statins before liver transplantation will be reviewed.

Detailed Description

Cardiovascular complications have emerged as a leading cause of early postoperative death following liver transplantation (LT), accounting for over 40% of early deaths. As a result, preventing postoperative cardiac complications has become a critical concern in the management of LT recipients.

Statin therapy has been suggested to improve perioperative and long-term outcomes in various surgical populations, primarily through LDL cholesterol reduction as well as pleiotropic effects, such as enhanced endothelial function and anti-inflammatory actions. However, evidence specifically examining the impact of preoperative statin therapy on cardiovascular outcomes after LT remains limited, highlighting the need for further research in this population.

This study aimed to address the current knowledge gap by investigating the association between preoperative statin use and the incidence of major adverse cardiovascular events within 30 days after liver transplantation in liver transplant recipients. Secondary outcomes included overall mortality, early allograft dysfunction, acute kidney injury, length of stay in the intensive care unit, duration of mechanical ventilation, and myocardial injury after non-cardiac surgery within 3 and 30 days after transplantation.

Conditions

Major Adverse Cardiovascular Events; Liver Transplantation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Control group

Patients who did not receive preoperative statin therapy

No interventions assigned to this group

Statin group

Patients who received preoperative statin therapy

Preoperative Statin Use

Intervention Type: DRUG

Administration of any statin medication prior to liver transplantation. Statin therapy was previously prescribed by the treating physician before the transplant procedure, not assigned by the study protocol.

Interventions

Preoperative Statin Use

Administration of any statin medication prior to liver transplantation. Statin therapy was previously prescribed by the treating physician before the transplant procedure, not assigned by the study protocol.

Intervention Type: DRUG

Other Intervention Names

HMG-CoA Reductase Inhibitor

Eligibility Criteria

Inclusion Criteria

• Adult patients aged ≥18 years who underwent liver transplantation

Exclusion Criteria

• Patients who underwent liver re-transplantation
• Patients with preoperative acute-on-chronic liver failure (ACLF)
• Patients with preoperative fulminant hepatic failure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jun-Gol Song

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2025-0645

Identifier Type: -

Identifier Source: org_study_id