Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology

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 associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range of 18-65 years

Cirrhosis with critical illness admitted to the Liver Intensive Care Unit

Disqualifiers

Age >65 years

Chronic renal disease

Pregnancy and peripartum cardiomyopathy

Valvular heart disease

Trial population

The target population for this study is all critically ill cirrhotic patients admitted to the Liver Intensive Care Unit of the Department of Hepatology, PGIMER Chandigarh

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiographic assessment

    Device

    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.

  • Histopathology and Immunohistochemistry

    Diagnostic test

    In patients who do not survive, we will take a trucut core biopsy from the ventricular myocardium, using ultrasound guidance. Cardiac tissue slices preserve the heterogeneous structure and multicellularity of the myocardium and allow its functional characterization. However, in this protocol, only those patients who consent to autopsy or those who consent to most mortem biopsy will be sampled for cardiac histology in CCM. Thus samples for histology and immunohistopathology will be available in only a few patients. For the immunohistochemistry study, the sections will be collected on the poly-L-lysine covered slides and dried in a thermostat, at 37°C, for 24 hours, for increasing the adherence of the biological material to the histological slide.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Cirrhotic cardiomyopathy2 interventions

Trial outcomes

Primary outcomes

1

Determine the prevalence of cirrhotic cardiomyopathy in critically ill patients with cirrhosis

CCM is independent of etiology, and all patients should be assessed for this under diagnosed complication of liver disease. The presence of metabolic syndrome, use of alcohol and cirrhosis can contribute synergistically as risk factors for clinically undiagnosed case of CCM. In a nutshell, the cirrhotic heart displays a variation of structure and size, atherosclerotic lesions, and myocardium hypertrophy with impaired functioning, with fibrosis and remodeling in late stages. The prevalence of patients with CCM diagnosed as per the 2020 CCM criteria of the AASLD will be assessed.

Time frame
At Enrollment

Secondary outcomes

1

Determine severity of cardiac dysfunction in critically ill patients with cirrhosis

Grade of left ventricular diastolic dysfunction will be assessed. Systolic function including stroke volume, velocity time integral and cardiac index will be assessed.

Time frame
At Enrollment
2

Determine the POCUS determinants of cardiac dysfunction in critically ill patients with cirrhosis

POCUS variables like cardiac output, SVRI, right ventricular variables, pulmonary artery pressure will be recorded.

Time frame
At Enrollment
3

Determine the cardiac histology changes in critically ill patients with cirrhosis

In patients who consent for autopsy or post mortem biopsy, cardiac, liver, renal, lung and splenic histological changes will be assessed.

Time frame
At the time of demise

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Dr. Madhumita PremkumarRecruiting160012, Sector-12, ChandigarhIndiaIndia

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