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

November 11, 2023 updated by: Fatma Mohamed Abdel-Naiem Mossad, Assiut University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fatma Mohamed Abdel-Naiem Mossad, internal medicine
  • Phone Number: 01012134549
  • Email: mof550736@gmail.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

-Study tools (in detail, e.g., lab methods, instruments, steps, chemicals,): all participants will be subjected to full history taking and examination with attention to inclusion and exclusion criteria and other comorbidities as follows:

  • Clinical evaluation: for:

    • history and possible etiology of NAFLD
    • confirming inclusion and exclusion criteria
    • Body weight and height, and body mass index (BMI)

  • Lab investigations:

    1. complete blood count
    2. liver function tests
    3. coagulation profile (PT - PC - INR)
    4. kidney function tests (urea, creatinine and e-GFR)
    5. HBA1C
    6. Complete lipid profile (total cholesterol, LDL, HDL and Triglycerides)
    7. Serum TSH
    8. electrolytes (Na, K, Calcium, MG, PO4)

  • Imaging:

    • Abdominal us
    • Fibroscan to assess liver stiffness (LSM) graded from F0 to F4 and degree of steatosis using the CAP score
    • 2-D conventional transthoracic echocardiography

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD
Device: Echocardiographic findings
Echocardiographic findings as Markers of Subclinical Cardiac dysfunction in Patients with Non-Alcoholic Fatty Liver Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate patients with NAFLD for early ECHOCARDIOGRAFPHIC signs of MYOCARDIAL DYSFUNCTION .
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
if there is any CORRELATION between the degree of STEATOSIS or FIBROSIS and the degree of MYOCARDIAL DYSFUNCTION .
Time Frame: 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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2023

Primary Completion (Estimated)

October 20, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

November 11, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Echocardiographic in NAFLD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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