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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04969055
• Other study ID #: 2020-qilu
• Status: Enrolling by invitation
• Start date: November 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cirrhotic Cardiomyopathy
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• Not
Not

Locations

Country	Name	City	State
China	Qilu Hospital , Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	N-terminal Pro-brain Natriuretic Peptide serum level	Venous blood sampling was performed in the morning, after a 12-h fast. serum levels of NT-proBNP were measured by an electrochemiluminescence immunoassay.	Within 48 hours after hospitalization
Primary	cirrhotic cardiomyopathy	Different levels of left ventricular diastolic dysfunction in patients with liver cirrhosis	Within 48 hours after hospitalization