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Completed

NCT Number: NCT07089589

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

The goal of this multicenter 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.

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Key information

Conditions

Major Adverse Cardiovascular Events Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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, graft failure, early allograft dysfunction, acute kidney injury, and length of stay in the intensive care unit.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Preoperative Statin Use

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.

Other names: HMG-CoA Reductase Inhibitor

Primary outcomes

  1. 30-day Major Adverse Cardiovascular Events

    Time frame: 30 days after liver transplantation

    The composite of cardiovascular death, heart failure, myocardial infarction, atrial fibrillation, ventricular arrhythmia, ischemic electrocardiogram changes (ST-segment depression or elevation) with chest tightness, pulmonary embolism, and stroke

Secondary outcomes

  1. Acute Kidney Injury

    Time frame: Within 7 days after liver transplantation

    Occurrence of acute kidney injury within 7 days post-transplantation, diagnosed according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

  2. Early Allograft Dysfunction

    Time frame: Within 7 days after liver transplantation

    Defined as serum bilirubin >10 mg/dL or international normalized ratio (INR) >1.6 on postoperative day (POD) 7, or alanine/aspartate aminotransferases >2000 IU/L within 7 days after transplantation

  3. Intensive Care Unit Length of Stay

    Time frame: From the date of liver transplantation until intensive care unit discharge, up to 600 days

    Total duration (days) of intensive care unit stay after liver transplantation

  4. Overall Mortality

    Time frame: From the date of liver transplantation to Mar 22, 2026

    Death from any cause after liver transplantation

  5. Overall Graft Failure

    Time frame: From the date of liver transplantation to Mar 22, 2026

    Recipient death or retransplantation for any cause

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Inje University Haeundae Paik Hospital
  • Samsung Medical Center

Registry information

Official study title

Preoperative Statin Use and Major Adverse Cardiovascular Events in Liver Transplant Recipients: A Multicenter Retrospective Cohort Study

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Apr 8, 2026

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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