Echocardiographic Findings as Markers of Subclinical Cardiac Dysfunction in Patients With Non-Alcoholic Fatty Liver Disease

NCT ID: NCT06130202

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-20
• Study Completion Date: 2025-12-20

Brief Summary

The investigators aim to evaluate patients with NAFLD for early echocardiographic signs of myocardial dysfunction and if there is any correlation between the degree of steatosis or fibrosis and the degree of myocardial dysfunction. This might be an early predictor for anticipating cardiac dysfunction in such cases who are naturally at more increased risk of cardiovascular complications.

Detailed Description

Individuals with Non-Alcoholic Fatty Liver Disease (NAFLD) have abnormal myocardial energy metabolism and reduced coronary functional capacity, even in the absence of risk factors for cardiovascular disease (CVD) ,Nonalcoholic fatty liver disease (NAFLD) is now recognized as the most common cause of chronic liver disease worldwide , Its prevalence has increased to more than 30% of adults in developed countries and its incidence is still rising , The majority of patients with NAFLD have simple steatosis but in up to one third of patients, NAFLD progresses to its more severe form nonalcoholic steatohepatitis (NASH) , NASH is characterized by liver inflammation and injury thereby determining the risk to develop liver fibrosis and cancer , NAFLD is considered the hepatic manifestation of the metabolic syndrome. However, the liver is not only a passive target but affects the pathogenesis of the metabolic syndrome and its complications. Conversely, pathophysiological changes in other organs such as in the adipose tissue, the intestinal barrier or the immune system have been identified as triggers and promoters of NAFLD progression , Metabolic syndrome is a cluster of metabolic abnormalities that identifies people at risk of diabetes and cardiovascular disease, whereas non-alcoholic fatty liver disease (NAFLD) is defined as a disorder with excess fat in the liver due to non-alcoholic causes. Two key components of metabolic syndrome, glucose and triglycerides, are overproduced by the fatty liver. The liver is therefore a key determinant of metabolic abnormalities. The prevalence of both metabolic syndrome and NAFLD increases with obesity. Both disorders predict type 2 diabetes, cardiovascular disease, non-alcoholic steatohepatitis (NASH), and hepatocellular carcinoma , Because metabolic syndrome can be defined in many different ways, NAFLD might be a more direct predictor of these diseases , Several cohort studies have consistently documented that NAFLD (especially in its more advanced forms) is associated with a higher risk of all-cause mortality and that the leading causes of death among patients with NAFLD are cardiovascular diseases (CVDs), followed by extrahepatic malignancies and liver-related complications , A growing body of evidence also indicates that NAFLD is strongly associated with an increased risk of major CVD events and other cardiac complications (ie, cardiomyopathy, cardiac valvular calcification and cardiac arrhythmias), independently of traditional cardiovascular risk factors.

Conditions

NAFLD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NAFLD

Echocardiographic findings

Intervention Type: DEVICE

Echocardiographic findings as Markers of Subclinical Cardiac dysfunction in Patients with Non-Alcoholic Fatty Liver Disease

Interventions

Echocardiographic findings

Echocardiographic findings as Markers of Subclinical Cardiac dysfunction in Patients with Non-Alcoholic Fatty Liver Disease

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• all NAFLD patients who will be seen in the outpatient clinic in our hospital. Diagnosis of NAFLD will be based on clinical history and examination, imaging and fibroscan results

Exclusion Criteria

1. Children less than 16 years

2. Adults more than 70 years

3. Known advanced cardiovascular disease as:

• advanced heart failure with reduced ejection fraction (HFrEF)
• history of recent acute myocardial event as acute coronary syndrome
• symptomatic chronic myocardial ischemia
• Known or recent diagnosis of rheumatic heart disease
• Known or recent diagnosis of congenital heart disease

4. Advanced comorbidities: advanced cancer, chronic kidney disease, advanced liver disease (decompensated cirrhosis), and advanced pulmonary disease.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Mohamed Abdel-Naiem Mossad

Principale Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatma Mohamed Abdel-Naiem Mossad, internal medicine

Role: CONTACT

mof550736@gmail.com

01012134549

Ahmed Aly Obeid Allah, prof internal medicine and c

Role: CONTACT

Ahmed_obiedallah@yahoo.com

01007556396

References

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Other Identifiers

Echocardiographic in NAFLD

Identifier Type: -

Identifier Source: org_study_id