Factors Associated With Posttransplant Cardiac Outcomes

NCT06290154 | Recruiting

• 1 other identifier: RG2024-022-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Liver Transplantation

Outcome Measures

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.

  3 months after liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

clinical data and comprehensive echocardiography variables

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jie Ren, Dr

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Jia Liu, Dr

CONTACT

15920190962; 395847953@qq.com

Jie Ren, Dr

CONTACT

13925155583; renj@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CN (2)