Cardiac Dysfunction in Patients with Fatty Liver Disease

Recruiting

• Conditions: NAFLD; Cardiac Disease; Fatty Liver; MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
• Interventions: Diagnostic Test: Echocardiographic assessment

• Registration Number: NCT06386094
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-07-15
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2027-08-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age range of 18-65 years
• metabolic dysfunction associated steatotic liver disease 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD	Echocardiographic assessment	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.

Primary Outcome Measures

Name	Time	Method
To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease	At Enrolment	Prevalence of CCM in the MASLD cohort

Secondary Outcome Measures

Name	Time	Method
Presence of myocardial abnormalities in CCM dysfunction	At Enrolment	Use of cardiac MRI or CT
Presence of perfusion abnormalities in CCM dysfunction	At Enrolment	Use of LV scintigraphy
All cause mortality in metabolic dysfunction associated steatotic liver disease	12 months after enrolment	All cause mortality will be recorded
Cardiac event related mortality in MASLD	12 months after enrolment	Cardiovascular events like incidence of arrhythmia, symptomatic heart failure related deaths will be recorded.
To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease	At Enrolment	Prevalence of CCM in the MASLD cohort, and grade of LV diastolic and systolic dysfunction

Trial Locations

Locations (1)

Dr. Madhumita Premkumar; 🇮🇳 Chandigarh, India