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

NCT04969055 | Unknown

• 1 other identifier: 2020-qilu
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Cirrhotic Cardiomyopathy

Keywords

Cirrhosis; cardiac dysfunction;Cardiac Imaging

Outcome Measures

Primary Outcomes (1)

• cirrhotic cardiomyopathy

  Different levels of left ventricular diastolic dysfunction in patients with liver cirrhosis

  Within 48 hours after hospitalization

Other Outcomes (1)

• N-terminal Pro-brain Natriuretic Peptide serum level

  Within 48 hours after hospitalization

Study Arms (2)

patients with liver cirrhosis

cirrhosis based on either clinical/radiological parameters or liver histology

Other: Not

control group

Healthy ubjects without known heart disease

Interventions

Not OTHER

Not

patients with liver cirrhosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital , Shandong University

Jinan, Shandong, China

Location

Related Publications (1)

• 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.

  PMID: 38407871 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Officials

• YanJing Gao, PhD.MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 20, 2021
• Study Start: November 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: April 25, 2022

Record last verified: 2021-07

Locations

CN (1)