Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease

Cardiac Disease Clinical Trial

Official title:

Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386094
• Other study ID #: INT/IEC/2023/SPL-902
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: April 2024
• Source: Post Graduate Institute of Medical Education and Research, Chandigarh
• Contact: Madhumita Premkumar
• Phone: 01722754777
• Email: drmadhumitap[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.

Description:

Nonalcoholic fatty liver disease (NAFLD) and heart failure (HF) are obesity-related conditions with high cardiovascular mortality. Many new studies have linked NAFLD to changes in myocardial energy metabolism, and to echocardiographic measurements of cardiac dysfunction especially heart failure with preserved ejection fraction. Cardiac dysfunction in NAFLD is related to the release of inflammatory cytokines among those with steatohepatitis (NASH). However composite models looking at coronary artery disease, systolic and diastolic heart failure and outcomes in patients with NAFLD are limited, and the few preliminary analyses of this relationship using histologically-defined NASH or lean NAFLD remain unclear.

In this project the investigators will screen patients with a diagnosis of 'non-alcoholic fatty liver disease' for presence of coronary artery disease, arrhythmias, cirrhotic cardiomyopathy and develop a model for cardiac dysfunction in such patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 15, 2025
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age range of 18-65 years

• NAFLD as diagnosed either by histology or clinical, laboratory, non invasive tests, USG findings and vibration controlled transient elastography (VCTE).

Exclusion Criteria:

• Age >65 years

• Chronic renal disease

• Pregnancy and peripartum cardiomyopathy

• Hypertension

• Valvular heart disease

• Sick sinus syndrome/ Pacemaker

• Cardiac rhythm disorder

• Hypothyroidism

• Hyperthyroidism

• Portal vein thrombosis

• Transjugular intrahepatic porto systemic shunt (TIPS) insertion

• Hepatocellular carcinoma

• Anemia Hb < 8gm/dl in females, and < 9 gm/dl in males at the time of assessment

Related Conditions & MeSH terms

• Cardiac Disease
• Fatty Liver
• Heart Diseases
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Diagnostic Test:
• Echocardiographic assessment
M mode, cross sectional and pulsed wave Doppler Echocardiographic examinations will be performed using a with a 2.5 MHz wide angle phased array transducer. Patients will be laid in left lateral position and examined in standard parasternal long and short axis and apical views. Short axis recordings will be performed at the level of the papillary muscles. M mode tracings will be recorded at the level of the papillary muscles and the aortic valves, with 2 -D guidance. LV wall thickness and cavity diameters will be measured by M mode, through the largest diameter of the ventricle, if possible, both in diastole and systole. Using the cross-sectional images as a guide, the M mode tracing of the left ventricle will obtained to calculate measurements according to the recommendations of American Society of Echocardiography.

Locations

Country	Name	City	State
India	Dr. Madhumita Premkumar	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Post Graduate Institute of Medical Education and Research, Chandigarh

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease	Prevalence of CCM in the NAFLD cohort	At Enrolment
Secondary	Presence of myocardial abnormalities in CCM dysfunction	Use of cardiac MRI or CT	At Enrolment
Secondary	Presence of perfusion abnormalities in CCM dysfunction	Use of LV scintigraphy	At Enrolment
Secondary	All cause mortality in NAFLD	All cause mortality will be recorded	12 months after enrolment
Secondary	Cardiac event related mortality in NAFLD	Cardiovascular events like incidence of arrhythmia, symptomatic heart failure related deaths will be recorded.	12 months after enrolment
Secondary	To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease	Prevalence of CCM in the NAFLD cohort, and grade of LV diastolic and systolic dysfunction	At Enrolment