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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Liver Cirrhosis; Cirrhotic Cardiomyopathy
• Intervention / Treatment: Other: Not

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital , Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From December 1, 2020 to December 31, 2021, The clear diagnosis of cirrhosis in patients caused by various reasons who have come to our hospital for digestive medicine.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with liver cirrhosis; cirrhosis based on either clinical/radiological parameters or liver histology	Other: Not; Not
control group; Healthy ubjects without known heart disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cirrhotic cardiomyopathy	Different levels of left ventricular diastolic dysfunction in patients with liver cirrhosis	Within 48 hours after hospitalization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Yanjing Gao, PhD.MD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Cirrhosis; cardiac dysfunction;Cardiac Imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Cardiomyopathies
• Other Study ID Numbers: 2020-qilu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No