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Recruiting NCT06290154

Factors Associated With Posttransplant Cardiac Outcomes

Observational Cardiovascular Diseases Liver Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, Liver Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • a composite outcome of new cardiovascular disease after liver transplantation [Time frame: 3 months after liver transplantation]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
  • the Third Affiliated Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06290154 · RG2024-022-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗