Factors Associated With Posttransplant Cardiac Outcomes

Cardiovascular Diseases Clinical Trial

Official title:

Factors Associated With Short-Term Major Adverse Cardiovascular Events After Liver Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06290154
• Other study ID #: RG2024-022-02
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Liver Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a composite outcome of new cardiovascular disease 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.	3 months after liver transplantation