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

• Conditions: Cirrhotic Cardiomyopathy; Liver Cirrhosis
• Interventions: Other: Not

• Registration Number: NCT04969055
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-11-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Study First Posted: 2021-07-20
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-25
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with liver cirrhosis	Not	cirrhosis based on either clinical/radiological parameters or liver histology

Primary Outcome Measures

Name	Time	Method
cirrhotic cardiomyopathy	Within 48 hours after hospitalization	Different levels of left ventricular diastolic dysfunction in patients with liver cirrhosis

Trial Locations

Locations (1)

Qilu Hospital , Shandong University; 🇨🇳 Jinan, Shandong, China