Cardiac Dysfunction in Patients with Fatty Liver Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Age >65 years

Chronic renal disease

Pregnancy and peripartum cardiomyopathy

Hypertension

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: MASLD1 intervention

Trial outcomes

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

Time frame
At Enrolment

Secondary outcomes

1

Presence of myocardial abnormalities in CCM dysfunction

Use of cardiac MRI or CT

Time frame
At Enrolment
2

Presence of perfusion abnormalities in CCM dysfunction

Use of LV scintigraphy

Time frame
At Enrolment
3

All cause mortality in metabolic dysfunction associated steatotic liver disease

All cause mortality will be recorded

Time frame
12 months after enrolment
4

Cardiac event related mortality in MASLD

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

Time frame
12 months after enrolment

Other outcomes

Sponsors and contacts

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