Cardiac Dysfunction in Patients with Fatty Liver Disease

NCT06386094 | Recruiting

• 2 other identifiers: INT/IEC/2023/SPL-902IEC/2024/1523 dt 3.12.2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  At Enrolment

Secondary Outcomes (5)

• Presence of myocardial abnormalities in CCM dysfunction

  At Enrolment

• Presence of perfusion abnormalities in CCM dysfunction

  At Enrolment

• All cause mortality in metabolic dysfunction associated steatotic liver disease

  12 months after enrolment

• Cardiac event related mortality in MASLD

  12 months after enrolment

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

  At Enrolment

Study Arms (1)

MASLD

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

Interventions

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.

MASLD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Dr. Madhumita Premkumar

Chandigarh, Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 26707365 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Sample

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Heart Diseases; Fatty Liver; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Madhumita Premkumar

CONTACT

01722754777; drmadhumitap@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: April 26, 2024
• Study Start: July 15, 2023
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

IN (1)