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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07089589
Enrollment
6898
Registered
2025-07-28
Start date
2008-01-02
Completion date
2026-03-22
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation, Major Adverse Cardiovascular Events

Keywords

statin, liver transplantation, major adverse cardiovascular events

Brief summary

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.

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

Interventions

DRUGPreoperative 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.

Sponsors

Asan Medical Center
Lead SponsorOTHER
Samsung Medical Center
CollaboratorOTHER
Inje University Haeundae Paik Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
30-day Major Adverse Cardiovascular Events30 days after liver transplantationThe 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

MeasureTime frameDescription
Acute Kidney InjuryWithin 7 days after liver transplantationOccurrence of acute kidney injury within 7 days post-transplantation, diagnosed according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Early Allograft DysfunctionWithin 7 days after liver transplantationDefined 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
Intensive Care Unit Length of StayFrom the date of liver transplantation until intensive care unit discharge, up to 600 daysTotal duration (days) of intensive care unit stay after liver transplantation
Overall MortalityFrom the date of liver transplantation to Mar 22, 2026Death from any cause after liver transplantation
Overall Graft FailureFrom the date of liver transplantation to Mar 22, 2026Recipient death or retransplantation for any cause

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026