An observational study in NAFLD, Cardiac Disease and Fatty Liver, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Observational
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 150 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
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The target population for this study is all patients with a diagnosis of metabolic dysfunction associated steatotic liver disease seen in the outpatient and inpatient services of the Department of Hepatology, PGIMER Chandigarh.
Exclusion Criteria:
Non invasive tests like APRI, FIB-4, , FAST scan and VCTE in the form of Fibroscan will be done and recorded. Liver biopsy would be done as per the clinical indication. Diagnosis of NAFLD will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy, imaging studies (ultrasonography and Doppler of spleno portal venous axis, VCTE) and liver biopsy where available.
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.
To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease
Prevalence of CCM in the MASLD cohort
Time frame: At Enrolment
Presence of myocardial abnormalities in CCM dysfunction
Use of cardiac MRI or CT
Time frame: At Enrolment
Presence of perfusion abnormalities in CCM dysfunction
Use of LV scintigraphy
Time frame: At Enrolment
All cause mortality in metabolic dysfunction associated steatotic liver disease
All cause mortality will be recorded
Time frame: 12 months after enrolment
Cardiac event related mortality in MASLD
Cardiovascular events like incidence of arrhythmia, symptomatic heart failure related deaths will be recorded.
Time frame: 12 months after enrolment
To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease
Prevalence of CCM in the MASLD cohort, and grade of LV diastolic and systolic dysfunction
Time frame: At Enrolment
Plan to share: Undecided
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Post Graduate Institute of Medical Education and Research, Chandigarh