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NCT Number: NCT06386094

Cardiac Dysfunction in Patients with Fatty Liver Disease

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.

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Key information

Conditions

NAFLD Arterial Occlusive Diseases Arteriosclerosis Cardiac Disease Cardiovascular Diseases Coronary Artery Disease Coronary Disease Digestive System Diseases Fatty Liver Heart Diseases Liver Diseases MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease Myocardial Ischemia Non-alcoholic Fatty Liver Disease Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Madhumita Premkumar

Chandigarh, 160012, India

Location status: Recruiting

Location contact

Dr. Madhumita Premkumar, MD

CONTACT

[email protected]

+9101722754777

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiographic assessment

Diagnostic Test

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.

Primary outcomes

  1. To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease

    Time frame: At Enrolment

    Prevalence of CCM in the MASLD cohort

Secondary outcomes

  1. Presence of myocardial abnormalities in CCM dysfunction

    Time frame: At Enrolment

    Use of cardiac MRI or CT

  2. Presence of perfusion abnormalities in CCM dysfunction

    Time frame: At Enrolment

    Use of LV scintigraphy

  3. All cause mortality in metabolic dysfunction associated steatotic liver disease

    Time frame: 12 months after enrolment

    All cause mortality will be recorded

  4. Cardiac event related mortality in MASLD

    Time frame: 12 months after enrolment

    Cardiovascular events like incidence of arrhythmia, symptomatic heart failure related deaths will be recorded.

  5. To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease

    Time frame: At Enrolment

    Prevalence of CCM in the MASLD cohort, and grade of LV diastolic and systolic dysfunction

Study contacts

Contact information is provided by the study sponsor or research team.

Madhumita Premkumar

CONTACT

[email protected]

01722754777

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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