Prevalence, Clinical Features and Risk Factors of Cirrhotic Cardiomyopathy Assessed by Two-dimensional Speckle Tracking Imaging

NCT ID: NCT04969055

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the prevalence of cirrhotic cardiomyopathy in patients with cirrhosis, and to analyze the correlation between the severity of cirrhosis and cardiac dysfunction. To investigate the risk factors for cirrhotic cardiomyopathy, and raise clinicians' awareness of cirrhotic cardiomyopathy, early assessment and intervention to improve long-term outcomes in patients with cirrhosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Liver cirrhosis is the terminal stage of the development of chronic liver disease caused by various reasons, and it is often accompanied by multiple complications. Late cirrhosis is often accompanied by obvious changes in liver and systemic hemodynamics. Patients with liver cirrhosis are in a highly dynamic cycle Status: lower arterial blood pressure, increased heart rate, increased cardiac output, peripheral vascular resistance, which often lead to changes in myocardial structure and function, called cirrhotic cardiomyopathy. Cirrhotic cardiomyopathy (CCM) is defined as cardiac dysfunction in patients with end-stage liver disease in the absence of prior heart disease. The true burden of CCM among patients with ESLD is currently unknown. Prior studies evaluated CCM prevalence and estimated it to be approximately 50%, however, this estimate was based on the old criteria. In 2020, the Cirrhotic Cardiomyopathy Association updated the diagnostic criteria for cirrhotic cardiomyopathy. At present, the true prevalence of cirrhotic cardiomyopathy still needs to be reassessed. In addition, studies on the risk factors for cirrhotic cardiomyopathy are rare. Based on the above research background, carry out this research.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis Cirrhotic Cardiomyopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with liver cirrhosis

cirrhosis based on either clinical/radiological parameters or liver histology

Not

Intervention Type OTHER

Not

control group

Healthy ubjects without known heart disease

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Not

Not

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The clear diagnosis of cirrhosis in patients caused by various reasons

Exclusion Criteria

* History of cardiovascular disease
* Diabetes
* High blood pressure
* Hepatocellular carcinoma (HCC) or other malignant tumors
* Patients with the chronic obstructive pulmonary disease
* Thyroid diseases
* Severe infection in the last 2 weeks
* History of liver transplantation and/or TIPS surgery
* Presence of stage 3 or above chronic kidney disease or acute chronic kidney disease
* Pregnant women
* Did not sign the informed consent form and refused to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

YanJing Gao, PhD.MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital , Shandong University

Jinan, Shandong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Xu H, Zhang Y, Gao Y. Prevalence and risk factors for cirrhotic cardiomyopathy: a prospective cross-sectional study. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):469-475. doi: 10.1097/MEG.0000000000002716. Epub 2024 Feb 16.

Reference Type DERIVED
PMID: 38407871 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-qilu

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

68Ga-FAPI PET/CT in Liver Fibrosis Patients
NCT04533828 UNKNOWN EARLY_PHASE1