Clinical trial NCT06386094: Cardiac Dysfunction in Patients with Fatty Liver Disease
Official title: Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NAFLD
Cardiac Disease
Fatty Liver
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: MASLD
Cirrhotic Cardiomyopathy
Heart failure in Cirrhosis
Coronary Artery Disease
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease
timeFrame: At Enrolment
Secondary outcomes:
measure: Presence of myocardial abnormalities in CCM dysfunction
timeFrame: At Enrolment
measure: Presence of perfusion abnormalities in CCM dysfunction
timeFrame: At Enrolment
measure: All cause mortality in metabolic dysfunction associated steatotic liver disease
timeFrame: 12 months after enrolment
measure: Cardiac event related mortality in MASLD
timeFrame: 12 months after enrolment
measure: To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease
timeFrame: At Enrolment
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Dr. Madhumita Premkumar
Study officials:
References:
citation: 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.