NAFLDNCT06130202
Echocardiographic Findings as Markers of Subclinical Cardiac Dysfunction in Patients With Non-Alcoholic Fatty Liver Disease
An observational study of NAFLD, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Echocardiographic findings
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2023to 20 Dec 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 17 to 70 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Children less than 16 years
- Adults more than 70 years
- 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
Show all 9Show fewer
- Known or recent diagnosis of rheumatic heart disease
- Known or recent diagnosis of congenital heart disease
- Advanced comorbidities: advanced cancer, chronic kidney disease, advanced liver disease (decompensated cirrhosis), and advanced pulmonary disease.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Echocardiographic findings
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic findingsDevice
Echocardiographic findings as Markers of Subclinical Cardiac dysfunction in Patients with Non-Alcoholic Fatty Liver Disease
| Study group | Role | What they receive |
|---|---|---|
| NAFLD | Not described Receives: Device: Echocardiographic findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate patients with NAFLD for early ECHOCARDIOGRAFPHIC signs of MYOCARDIAL DYSFUNCTION .
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
if there is any CORRELATION between the degree of STEATOSIS or FIBROSIS and the degree of MYOCARDIAL DYSFUNCTION .
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start20 Nov 2023 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mohamed Abdel-Naiem Mossad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130202
- Sponsor's protocol ID
- Echocardiographic in NAFLD
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365Saab S, Manne V, Nieto J, Schwimmer JB, Chalasani NP. Nonalcoholic Fatty Liver Disease in Latinos. Clin Gastroenterol Hepatol. 2016 Jan;14(1):5-12; quiz e9-10. doi: 10.1016/j.cgh.2015.05.001. Epub 2015 May 11.
PubMed 25976180Pan JJ, Fallon MB. Gender and racial differences in nonalcoholic fatty liver disease. World J Hepatol. 2014 May 27;6(5):274-83. doi: 10.4254/wjh.v6.i5.274.
PubMed 24868321Fleischman MW, Budoff M, Zeb I, Li D, Foster T. NAFLD prevalence differs among hispanic subgroups: the Multi-Ethnic Study of Atherosclerosis. World J Gastroenterol. 2014 May 7;20(17):4987-93. doi: 10.3748/wjg.v20.i17.4987.
PubMed 24803810Younossi ZM, Golabi P, de Avila L, Paik JM, Srishord M, Fukui N, Qiu Y, Burns L, Afendy A, Nader F. The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis. J Hepatol. 2019 Oct;71(4):793-801. doi: 10.1016/j.jhep.2019.06.021. Epub 2019 Jul 4.
PubMed 31279902Harrison SA, Gawrieh S, Roberts K, Lisanti CJ, Schwope RB, Cebe KM, Paradis V, Bedossa P, Aldridge Whitehead JM, Labourdette A, Miette V, Neubauer S, Fournier C, Paredes AH, Alkhouri N. Prospective evaluation of the prevalence of non-alcoholic fatty liver disease and steatohepatitis in a large middle-aged US cohort. J Hepatol. 2021 Aug;75(2):284-291. doi: 10.1016/j.jhep.2021.02.034. Epub 2021 Mar 18.
PubMed 33746083Allen AM, Therneau TM, Larson JJ, Coward A, Somers VK, Kamath PS. Nonalcoholic fatty liver disease incidence and impact on metabolic burden and death: A 20 year-community study. Hepatology. 2018 May;67(5):1726-1736. doi: 10.1002/hep.29546. Epub 2018 Mar 23.
PubMed 28941364Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.
PubMed 28714183Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.
PubMed 32044314
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Findings as Markers of Subclinical Cardiac Dysfunction in Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06130202
- Acronym / sponsor ID
- Echocardiographic in NAFLD
- Conditions
- NAFLD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 14 Nov 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAFLD | – | Device: Echocardiographic findings |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- Children less than 16 years
- Adults more than 70 years
- Known advanced cardiovascular disease as:
- Advanced comorbidities: advanced cancer, chronic kidney disease, advanced liver disease (decompensated cirrhosis), and advanced pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic findingsEchocardiographic findings as Markers of Subclinical Cardiac dysfunction in Patients with Non-Alcoholic Fatty Liver Disease | Device | NAFLD |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 26707365Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Background: PubMed 25976180Saab S, Manne V, Nieto J, Schwimmer JB, Chalasani NP. Nonalcoholic Fatty Liver Disease in Latinos. Clin Gastroenterol Hepatol. 2016 Jan;14(1):5-12; quiz e9-10. doi: 10.1016/j.cgh.2015.05.001. Epub 2015 May 11.
- Background: PubMed 24868321Pan JJ, Fallon MB. Gender and racial differences in nonalcoholic fatty liver disease. World J Hepatol. 2014 May 27;6(5):274-83. doi: 10.4254/wjh.v6.i5.274.
- Background: PubMed 24803810Fleischman MW, Budoff M, Zeb I, Li D, Foster T. NAFLD prevalence differs among hispanic subgroups: the Multi-Ethnic Study of Atherosclerosis. World J Gastroenterol. 2014 May 7;20(17):4987-93. doi: 10.3748/wjg.v20.i17.4987.
- Background: PubMed 31279902Younossi ZM, Golabi P, de Avila L, Paik JM, Srishord M, Fukui N, Qiu Y, Burns L, Afendy A, Nader F. The global epidemiology of NAFLD and NASH in patients with type 2 diabetes: A systematic review and meta-analysis. J Hepatol. 2019 Oct;71(4):793-801. doi: 10.1016/j.jhep.2019.06.021. Epub 2019 Jul 4.
- Background: PubMed 33746083Harrison SA, Gawrieh S, Roberts K, Lisanti CJ, Schwope RB, Cebe KM, Paradis V, Bedossa P, Aldridge Whitehead JM, Labourdette A, Miette V, Neubauer S, Fournier C, Paredes AH, Alkhouri N. Prospective evaluation of the prevalence of non-alcoholic fatty liver disease and steatohepatitis in a large middle-aged US cohort. J Hepatol. 2021 Aug;75(2):284-291. doi: 10.1016/j.jhep.2021.02.034. Epub 2021 Mar 18.
- Background: PubMed 28941364Allen AM, Therneau TM, Larson JJ, Coward A, Somers VK, Kamath PS. Nonalcoholic fatty liver disease incidence and impact on metabolic burden and death: A 20 year-community study. Hepatology. 2018 May;67(5):1726-1736. doi: 10.1002/hep.29546. Epub 2018 Mar 23.
- Background: PubMed 28714183Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.
- Background: PubMed 32044314Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD, run by Assiut University.
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 1 inclusion and 9 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Fatma Mohamed Abdel-Naiem Mossad, internal medicine (01012134549, mof550736@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate patients with NAFLD for early ECHOCARDIOGRAFPHIC signs of MYOCARDIAL DYSFUNCTION . (time frame: through study completion, an average of 1 year). 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 NCT06130202, which also lists 9 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 14 Nov 2023.