Clinical trial NCT04969055: Prevalence, Clinical Features and Risk Factors of Cirrhotic Cardiomyopathy Assessed by Two-dimensional Speckle Tracking Imaging
Official title: Prevalence, Clinical Features and Risk Factors of Cirrhotic Cardiomyopathy Assessed by Two-dimensional Speckle Tracking Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Cirrhotic Cardiomyopathy
Keywords: Cirrhosis; cardiac dysfunction;Cardiac Imaging
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: cirrhotic cardiomyopathy
timeFrame: Within 48 hours after hospitalization
Secondary outcomes:
Other outcomes:
measure: N-terminal Pro-brain Natriuretic Peptide serum level
timeFrame: Within 48 hours after hospitalization
Locations:
city: Jinan
country: China
facility: Qilu Hospital , Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: YanJing Gao, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References: