Liver SteatosesNCT05790057
Subclinical Cardiovascular Changes in NAFLD Patient (Predictive Value of Speckle Tracking Echocardiography )
An observational study of Liver Steatoses, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Steatoses
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients above age of 18 years old
- All patients showing degree of fibrosis and steatosis
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university
Asyut, Assuit, 71515
reem e mahdy, professor, 01096608866 ext. 02, reemezzat1@gmail.com
About this study
Official title: 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
- the role of speckle tracking echocardiogram in detection of subclinical cardiovascular complication in NAFLD patients
- the role of fibroscan in diagnosis of nonalcoholic fatty liver the participant will be examined by fibroscan and speckle tracking echocardiogram
Read the 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:
- liver function
- lipid profile
- HBA1C
- Renal function
- Erythrocyte sedimentation rate ( ESR) \& C - Reactive protein test ( CRP)
- Imaging including:
- Fibroscan : It is a special non-invasive ultrasound technology that measures liver stiffness (hardness) and fatty changes in the liver
- Ultrasonography
- Conventional Echocardiography : It is an imaging technique that enables accurate assessment of cardiac structures and cardiac function
- Speckle Tracking Echocardiography:
- Study Scores including:
- ASCVD risk score (Atherosclerotic cardiovascular disease )
- 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 .
- Conditions
- Liver Steatoses
- Medical subject headings
- Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensitivity of fibroscan in diagnosis of NAFLD
analysis of the results of fibroscan and test the sensitivity of fibroscan in measurement the degree of steatosis and diagnosis of NAFLD
Measured: baseline
role of speckle tracking echocardiogram in detection of subclinical cardiovascular complications of NAFLD
speckle tracking echocardiogram will be used to to find any cardiac abnormality such as myocardial infarction , valvular diseases in NAFLD patients
Measured: baseline
comparison between conventional echocardiogram and speckle tracking echocardiogram in detection of subclinical cardiovascular complications of NAFLD patients
comparison between the results and measurements of both conventional echocardiogram and speckle tracking echocardiogram
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver SteatosesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Magdy Eid, Assiut University
- Investigators
- lobna m abdelwaheed, professor, Study director, supervisor of the research ( professor of internal medicine Assiut universitysoheir m kasem, professor, Study director, supervisor of the research ( professor of internal medicine Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790057
- Sponsor's protocol ID
- cardiac complication in NAFLD
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kasper P, Martin A, Lang S, Kutting F, Goeser T, Demir M, Steffen HM. NAFLD and cardiovascular diseases: a clinical review. Clin Res Cardiol. 2021 Jul;110(7):921-937. doi: 10.1007/s00392-020-01709-7. Epub 2020 Jul 21.
PubMed 32696080Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.
PubMed 32027858Oeda S, Tanaka K, Oshima A, Matsumoto Y, Sueoka E, Takahashi H. Diagnostic Accuracy of FibroScan and Factors Affecting Measurements. Diagnostics (Basel). 2020 Nov 12;10(11):940. doi: 10.3390/diagnostics10110940.
PubMed 33198092Pathik P, Ravindra S, Ajay C, Prasad B, Jatin P, Prabha S. Fibroscan versus simple noninvasive screening tools in predicting fibrosis in high-risk nonalcoholic fatty liver disease patients from Western India. Ann Gastroenterol. 2015 Apr-Jun;28(2):281-286.
PubMed 25830783Anstee QM, Mantovani A, Tilg H, Targher G. Risk of cardiomyopathy and cardiac arrhythmias in patients with nonalcoholic fatty liver disease. Nat Rev Gastroenterol Hepatol. 2018 Jul;15(7):425-439. doi: 10.1038/s41575-018-0010-0.
PubMed 29713021Zamirian M MD, Samiee E MD, Moaref A MD, Abtahi F MD, Tahamtan M MD. Assessment of Subclinical Myocardial Changes in Non-Alcoholic Fatty Liver Disease: A Case-Control Study Using Speckle Tracking Echocardiography. Iran J Med Sci. 2018 Sep;43(5):466-472.
PubMed 30214098
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Cardiovascular Changes in Patient With Non Alcoholic Fatty Liver Disease (Predictive Value of Speckle Tracking Echocardiography )
- ClinicalTrials.gov ID
- NCT05790057
- Acronym / sponsor ID
- cardiac complication in NAFLD
- Conditions
- Liver Steatoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- the role of speckle tracking echocardiogram in detection of subclinical cardiovascular complication in NAFLD patients
- the role of fibroscan in diagnosis of nonalcoholic fatty liver the participant will be examined by fibroscan and speckle tracking echocardiogram
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:
- liver function
- lipid profile
- HBA1C
- Renal function
- Erythrocyte sedimentation rate ( ESR) \& C - Reactive protein test ( CRP)
- Imaging including:
- Fibroscan : It is a special non-invasive ultrasound technology that measures liver stiffness (hardness) and fatty changes in the liver
- Ultrasonography
- Conventional Echocardiography : It is an imaging technique that enables accurate assessment of cardiac structures and cardiac function
- Speckle Tracking Echocardiography:
- Study Scores including:
- ASCVD risk score (Atherosclerotic cardiovascular disease )
- 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients above age of 18 years old
- All patients showing degree of fibrosis and steatosis
- -
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 32696080Kasper P, Martin A, Lang S, Kutting F, Goeser T, Demir M, Steffen HM. NAFLD and cardiovascular diseases: a clinical review. Clin Res Cardiol. 2021 Jul;110(7):921-937. doi: 10.1007/s00392-020-01709-7. Epub 2020 Jul 21.
- Background: PubMed 32027858Newsome PN, Sasso M, Deeks JJ, Paredes A, Boursier J, Chan WK, Yilmaz Y, Czernichow S, Zheng MH, Wong VW, Allison M, Tsochatzis E, Anstee QM, Sheridan DA, Eddowes PJ, Guha IN, Cobbold JF, Paradis V, Bedossa P, Miette V, Fournier-Poizat C, Sandrin L, Harrison SA. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):362-373. doi: 10.1016/S2468-1253(19)30383-8. Epub 2020 Feb 3.
- Background: PubMed 33198092Oeda S, Tanaka K, Oshima A, Matsumoto Y, Sueoka E, Takahashi H. Diagnostic Accuracy of FibroScan and Factors Affecting Measurements. Diagnostics (Basel). 2020 Nov 12;10(11):940. doi: 10.3390/diagnostics10110940.
- Background: PubMed 25830783Pathik P, Ravindra S, Ajay C, Prasad B, Jatin P, Prabha S. Fibroscan versus simple noninvasive screening tools in predicting fibrosis in high-risk nonalcoholic fatty liver disease patients from Western India. Ann Gastroenterol. 2015 Apr-Jun;28(2):281-286.
- Background: PubMed 29713021Anstee QM, Mantovani A, Tilg H, Targher G. Risk of cardiomyopathy and cardiac arrhythmias in patients with nonalcoholic fatty liver disease. Nat Rev Gastroenterol Hepatol. 2018 Jul;15(7):425-439. doi: 10.1038/s41575-018-0010-0.
- Background: PubMed 30214098Zamirian M MD, Samiee E MD, Moaref A MD, Abtahi F MD, Tahamtan M MD. Assessment of Subclinical Myocardial Changes in Non-Alcoholic Fatty Liver Disease: A Case-Control Study Using Speckle Tracking Echocardiography. Iran J Med Sci. 2018 Sep;43(5):466-472.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lobna m abdelwaheed, professor study director
supervisor of the research ( professor of internal medicine Assiut university
soheir m kasem, professor study director
supervisor of the research ( professor of internal medicine Assiut university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Steatoses, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact omar m magdy, postgraduate (01062983336 ext. 02, omar.megooz96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensitivity of fibroscan in diagnosis of NAFLD (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05790057, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.