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Cardiac Dysfunction in Patients with Fatty Liver Disease

Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06386094
Enrollment
150
Registered
2024-04-26
Start date
2023-07-15
Completion date
2027-11-15
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Fatty Liver, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD

Keywords

MASLD, Cirrhotic Cardiomyopathy, Heart failure in Cirrhosis, Coronary Artery Disease

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.

Interventions

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.

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver diseaseAt EnrolmentPrevalence of CCM in the MASLD cohort

Secondary

MeasureTime frameDescription
Presence of myocardial abnormalities in CCM dysfunctionAt EnrolmentUse of cardiac MRI or CT
Presence of perfusion abnormalities in CCM dysfunctionAt EnrolmentUse of LV scintigraphy
All cause mortality in metabolic dysfunction associated steatotic liver disease12 months after enrolmentAll cause mortality will be recorded
Cardiac event related mortality in MASLD12 months after enrolmentCardiovascular 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 diseaseAt EnrolmentPrevalence of CCM in the MASLD cohort, and grade of LV diastolic and systolic dysfunction

Countries

India

Contacts

Primary ContactMadhumita Premkumar
drmadhumitap@gmail.com01722754777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026