Clinical trial NCT06290154: Factors Associated With Posttransplant Cardiac Outcomes
Official title: Factors Associated With Short-Term Major Adverse Cardiovascular Events After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Liver Transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end-stage cirrhosis who are going to undergo liver transplantation in the Third Affiliated Hospital of 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.


Eligibility criteria: 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.

Primary outcomes:
measure: a composite outcome of new cardiovascular disease after liver transplantation
timeFrame: 3 months after liver transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Jie Ren, Dr
role: STUDY_DIRECTOR
References: