Factors Associated With Posttransplant Cardiac Outcomes

Recruiting

• Conditions: Liver Transplantation; Cardiovascular Diseases

• Registration Number: NCT06290154
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Study Start: 2024-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-25
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age > 18 years,
• End-stage cirrhosis patients who will receive liver transplantation,
• Patients voluntarily take part in the study and write informed consent.

Exclusion Criteria

• Decreased left ventricular systolic function (ejection fraction <45%),
• Significant uncorrectable structural cardiac abnormalities (eg, symptomatic coronary heart disease, advanced cardiomyopathy, severe valvular disease, severe congenital heart disease, etc),
• Uncontrolled pulmonary hypertension defined as pulmonary arterial systolic pressure ≧ 35mm Hg at rest despite maximal medical management,
• Circulatory or respiratory system with a score of 4 based on the preoperative Organ Dysfunction (CLIF-SOFA) score,
• Second-time liver transplantation,
• Combined organ transplantation,
• Satisfactory quality echocardiography could not be obtained before operation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a composite outcome of new cardiovascular disease after liver transplantation	3 months after liver transplantation	new symptomatic CAD, new heart failure (systolic and/or diastolic), new arrhythmia (atrial and/or ventricular), and/or new cardiac arrest, or cardiac death.

Trial Locations

Locations (2)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

the Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China