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RecruitingNCT06290154Updated Aug 27, 2024

Factors Associated With Posttransplant Cardiac Outcomes

An observational study in Cardiovascular Diseases and Liver Transplantation, sponsored by Sun Yat-sen University. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Liver Transplantation
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's planned enrollment of 200 is below the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after liver transplantation

07

Study locations

2 of 2 sites recruiting
  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    • Jia Liu · Contact · 395847853@qq.com · +8615920190962
    • Jia Liu · Principal investigator
    Recruiting
  • the Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    • Jia Liu, Dr · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06290154
Responsible party
Jia Liu (Dr, Sun Yat-sen University) — Principal investigator
First posted
Mar 4, 2024
Start date
Apr 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 27, 2024

Study contacts

Jia Liu, Dr
Contact
395847953@qq.com
15920190962
Jie Ren, Dr
Contact
renj@mail.sysu.edu.cn
13925155583
Jie Ren, Dr
study director · Third Affiliated Hospital, Sun Yat-Sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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