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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06130202
Collaborator
(none)
165
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Echocardiographic findings

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
165 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Echocardiographic Findings as Markers of Subclinical Cardiac Dysfunction in Patients With Non-Alcoholic Fatty Liver Disease
Anticipated Study Start Date :
Nov 20, 2023
Anticipated Primary Completion Date :
Oct 20, 2025
Anticipated Study Completion Date :
Dec 20, 2025

Arms and Interventions

Arm Intervention/Treatment
NAFLD

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

Outcome Measures

Primary Outcome Measures

  1. evaluate patients with NAFLD for early ECHOCARDIOGRAFPHIC signs of MYOCARDIAL DYSFUNCTION . [through study completion, an average of 1 year]

    Patient outcomes will be recorded and analyzed. Statistical analysis will be done using measures of correlation and regression using up-to-date statistical analysis tools.

Secondary Outcome Measures

  1. if there is any CORRELATION between the degree of STEATOSIS or FIBROSIS and the degree of MYOCARDIAL DYSFUNCTION . [through study completion, an average of 1 year]

    Patient outcomes will be recorded and analyzed. Statistical analysis will be done using measures of correlation and regression using up-to-date statistical analysis tools

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 70 Years
Sexes Eligible for Study:
All
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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatma Mohamed Abdel-Naiem Mossad, Principale Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06130202
Other Study ID Numbers:
  • Echocardiographic in NAFLD
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2023