NCT06130202

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

November 14, 2023

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

October 20, 2023

Last Update Submit

November 11, 2023

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 .

    through study completion, an average of 1 year

Study Arms (1)

NAFLD

Device: Echocardiographic findings

Interventions

Echocardiographic findingsDEVICE

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

NAFLD

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 26707365BACKGROUND

  • Saab 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.

    PMID: 25976180BACKGROUND

  • Pan 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.

    PMID: 24868321BACKGROUND

  • Fleischman 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.

    PMID: 24803810BACKGROUND

  • Younossi 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.

    PMID: 31279902BACKGROUND

  • Harrison 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.

    PMID: 33746083BACKGROUND

  • Allen 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.

    PMID: 28941364BACKGROUND

  • Chalasani 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.

    PMID: 28714183BACKGROUND

  • Eslam 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.

    PMID: 32044314BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Fatma Mohamed Abdel-Naiem Mossad, internal medicine

CONTACT

01012134549mof550736@gmail.com

Ahmed Aly Obeid Allah, prof internal medicine and c

CONTACT

01007556396Ahmed_obiedallah@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principale Investigator

Study Record Dates

First Submitted

October 20, 2023

First Posted

November 14, 2023

Study Start

November 20, 2023

Primary Completion

October 20, 2025

Study Completion

December 20, 2025

Last Updated

November 14, 2023

Record last verified: 2023-10