Subclinical Cardiovascular Changes in NAFLD Patient (Predictive Value of Speckle Tracking Echocardiography )

March 28, 2023 updated by: Omar Mohamed Magdy Eid, Assiut University

Subclinical Cardiovascular Changes in Patient With Non Alcoholic Fatty Liver Disease (Predictive Value of Speckle Tracking Echocardiography )

the goal of this study (observational study ) is to learn about the subclinical cardiovascular changes in patients with nonalcoholic fatty liver . the main questions it aims to answer are

  1. the role of speckle tracking echocardiogram in detection of subclinical cardiovascular complication in NAFLD patients
  2. the role of fibroscan in diagnosis of nonalcoholic fatty liver the participant will be examined by fibroscan and speckle tracking echocardiogram

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The diagnosis of Non Alcoholic Fatty Liver Disease ( NAFLD) requires evidence of hepatic steatosis by either imaging or histology and the exclusion of secondary causes of hepatic fat accumulation such as use of medications e.g ( corticosteroids , amiodarone , methotrexate ) , hereditary disorders e.g ( Wilson's disease , alpha 1 antitrypsin deficiency ) or viral infections additionally daily alcoholic consumption mustn't exceed 30g for men and 20g for women 1 Nonalcoholic fatty liver disease is rising in prevalence along with levels of obesity and type 2 diabetes mellitus such that it is now the most common cause of chronic liver disease worldwide prevalence in general population is 25 to 30% but this rises to 70% in patients with obesity and type 2 diabetes mellitus.

Fibroscan is an evidence based ,transient elastography instrument for noninvasive evaluation of liver steatosis and fibrosis There are various studies substantiating the use of fibroscan in NAFLD. In a study by Wong et al 246 patients underwent liver stiffness measurement by fibroscan , In a study carried out by Yoneda et al , AUROC for F1 , F2 , F3 , F4 fibrosis were 0.881, 0.876 , 0.914 and 0.997 , respectively. Musso et al showed that for nonalcoholic steatohepatitis (NASH) with advanced fibrosis, , sensitivity and specificity of fibroscan were 0.85, 0.90 , 0.97 and 0.94 . Another study from India by sarin et al showed similar efficacy of fibroscan in NAFLD in patients from Northern India4 Convincing evidence now substantiates a strong association between the presence and severity of ( NAFLD) and the risk of cardiomyopathy (mainly left ventricular dysfunction and hypertrophy , possibly leading to heart failure and arrhythmias 5 Speckle-tracking Echocardiography a non-invasive ultrasound imaging technique allows an objective and quantitative evaluation of global and regional myocardial function independently from the angle of insonation and cardiac translational movements based on an analysis of the spatial dislocation of speckles on routine 2 dimensional sonograms Because of its potential benefits in the measurement of left ventricular function along with other systolic and diastolic echocardiographic parameters of left ventricular function measurement this novel technique is used in this study to assess the relationship between NAFLD and subclinical myocardial dysfunction

All participants will be subjected to full history and examination including :

  • Demographic data with special habits
  • Underlying comorbidity (Diabetes mellitus , Hypertension , Cardiovascular disease
  • Symptoms of NAFLD eg: fatigue , loss of appetite , weight loss , pale stool

  • Symptoms of cardiac dysfunction including eg :

    • heart failure ( shortness of breath , fatigue , swelling of the feet ankles ,legs , abdomen or neck veins )
    • arrhythmia ( fluttering feelings in the chest [palpitations} )
    • heart attack ( chest pain or discomfort upper back or neck pain , indigestion , heartburn , nausea or vomiting , extreme fatigue ,upper body discomfort , dizziness and shortness of breath )
  • Therapeutic history eg : drugs causing NAFLD ( corticosteroids , antidepressants , antipsychotics ) antihypertensive drugs , drugs to control Diabetes mellitus , Antiarrhythmic & anti ischemic drugs

  • EXAMINATION : *vital signs ( blood pressure , pulse , temperature , respiratory rate ) * dyslipidemic signs * cardiovascular examination chest examination * lower limb pulsation

    • Laboratory investigation including:

      1. liver function
      2. lipid profile
      3. HBA1C
      4. Renal function
      5. Erythrocyte sedimentation rate ( ESR) & C - Reactive protein test ( CRP)

    • Imaging including:

      1. Fibroscan :

        It is a special non-invasive ultrasound technology that measures liver stiffness (hardness) and fatty changes in the liver

      2. Ultrasonography

      3. Conventional Echocardiography :

        It is an imaging technique that enables accurate assessment of cardiac structures and cardiac function

      4. Speckle Tracking Echocardiography:

    • Study Scores including:

      1. ASCVD risk score (Atherosclerotic cardiovascular disease )

      2. CHA2DS2-VASc score

        • Sample size Sample size was calculated using Epi-Info7 based on prevalence of NAFLD and its subclinical cardiovascular abnormalities , the minimum patients required for this study is 60 patient
    • statistical analysis : statistical analysis will be performed using SPSS statistics ( statistical package for the social sciences) version 20 (USA) , patient characteristics and outcomes will be reported using standard descriptive statistics : frequency (percentage ) for categorical variables and mean (SD) continuous variables .

Study Type

Observational

Enrollment (Anticipated)

60

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

Study Contact Backup

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71515
        • Assiut University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

any patient above 18 years no specific gender is required , with no comorbidities ( not cardiac not hypertensive , no chronic liver disease , no hepatocellular carcinoma , not alcoholic

Description

Inclusion Criteria:

  1. Patients above age of 18 years old

  2. All patients showing degree of fibrosis and steatosis

    -

Exclusion Criteria:

  • 1-Patients diagnosed with cardiac disease (previous or current )

    2-patients known to have chronic liver disease

    3-patients younger than 18 years old

    4-patients with hepatocellular cancer

    5-patients know to be alcoholic

    6-patients with previous history of hypertension

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the sensitivity of fibroscan in diagnosis of NAFLD
Time Frame: baseline
analysis of the results of fibroscan and test the sensitivity of fibroscan in measurement the degree of steatosis and diagnosis of NAFLD
baseline
role of speckle tracking echocardiogram in detection of subclinical cardiovascular complications of NAFLD
Time Frame: baseline
speckle tracking echocardiogram will be used to to find any cardiac abnormality such as myocardial infarction , valvular diseases in NAFLD patients
baseline
comparison between conventional echocardiogram and speckle tracking echocardiogram in detection of subclinical cardiovascular complications of NAFLD patients
Time Frame: baseline
comparison between the results and measurements of both conventional echocardiogram and speckle tracking echocardiogram
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: lobna m abdelwaheed, professor, supervisor of the research ( professor of internal medicine Assiut university
  • Study Director: soheir m kasem, professor, supervisor of the research ( professor of internal medicine 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 (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cardiac complication 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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