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Status unknownNCT04976764Updated Jul 26, 2021

The Correlation Between Cirrhotic Cardiomyopathy and Perioperative Cardiovascular Events in Liver Transplantation

An observational study in Cirrhosis, Liver, sponsored by The Affiliated Hospital of Qingdao University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-26.

Sponsored by The Affiliated Hospital of Qingdao University · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
850
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Cirrhosis, Liver

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In context

Liver Cirrhosis

1,668 studies on the registry are indexed under Liver Cirrhosis; 360 are open to participants now.

This study's planned enrollment of 850 is above the median of 152 across 605 observational studies indexed under Liver Cirrhosis.

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Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 146 studies on the registry; 55 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

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

  1. Diagnostic criteria for decompensated liver cirrhosis: according to the guidelines for diagnosis and treatment of liver cirrhosis in 2019;
  2. 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.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
850 participants (estimated)
Patient registry
No

Groups and cohorts

  • liver cirrhosis with cirrhotic cardiomyopathy
  • liver cirrhosis without cirrhotic cardiomyopathy
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What researchers measure

Primary outcomes

  1. perioperative cardiovascular events

    there are differences between 2 groups.

    Time frame: 2012.1.1-2022.8

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04976764
Responsible party
Sponsor
First posted
Jul 26, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Aug 1, 2022 (estimated)
Completion
Sep 1, 2023 (estimated)
Last update
Jul 26, 2021

Study contacts

shenghua Bi
Contact
bsh112359@163.com
+8618863608195
xue Jing
Contact
jingxue@qdu.edu.cn
+8618661807575

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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