NCT04976764

Brief Summary

Liver transplantation is an effective treatment for end-stage liver disease. Cardiovascular complications are the common causes of death in liver transplant recipients. The presence of cirrhosis cardiomyopathy has a potential impact on the prognosis of liver transplant recipients. Therefore, it is important to identify the high risk factors with cirrhotic cardiomyopathy before transplantation, so as to intervene earlier and improve the prognosis of patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 15, 2021

Last Update Submit

July 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • perioperative cardiovascular events

    there are differences between 2 groups.

    2012.1.1-2022.8

Study Arms (2)

liver cirrhosis with cirrhotic cardiomyopathy

liver cirrhosis without cirrhotic cardiomyopathy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In this study, the patients with decompensated liver cirrhosis who received liver transplantation from January 1, 2012 to June 1, 2021 in the Affiliated Hospital of Qingdao University were reviewed through the Yidu cloud platform. According to the 2019 cirrhosis cardiomyopathy (CCM) diagnostic criteria, they were divided into two groups according to the presence or absence of cardiomyopathy.The incidence of CCM , the predictive factors of perioperative and postoperative cardiovascular complications were followed up. At the same time,we analysed the influence of CCM on the survival rate.

You may qualify if:

  • Diagnostic criteria for decompensated liver cirrhosis: according to the guidelines for diagnosis and treatment of liver cirrhosis in 2019;
  • Diagnostic criteria for cirrhotic cardiomyopathy: in accordance with the revised criteria of CCM of international multidisciplinary Alliance for cirrhotic cardiomyopathy in 2019, the preoperative echocardiographic images of all patients were reviewed, and the systolic and diastolic dysfunction of all patients were evaluated.

You may not qualify if:

  • the compensatory liver cirrhosis, primary liver cancer without liver cirrhosis
  • Multiple organ transplantation or multiple organ transplantation
  • The preoperative echocardiographic data were not fully recorded, so that the exact diagnosis could not be made
  • There was no follow-up data or baseline data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2021

First Posted

July 26, 2021

Study Start

August 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2023

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share