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RECRUITINGOBSERVATIONAL

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

Diagnosis and Pathogenetic Mechanisms in Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following: - Age range of 18-65 years - Cirrhosis with critical illness admitted to the Liver Intensive Care Unit Who Should NOT Join This Trial: - Age \>65 years - Chronic renal disease - Pregnancy and peripartum cardiomyopathy - Valvular heart disease - Sick sinus syndrome/ Pacemaker - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following: * Age range of 18-65 years * Cirrhosis with critical illness admitted to the Liver Intensive Care Unit Exclusion Criteria: * Age \>65 years * Chronic renal disease * Pregnancy and peripartum cardiomyopathy * Valvular heart disease * Sick sinus syndrome/ Pacemaker * 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

Treatments Being Tested

DEVICE

Echocardiographic assessment

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.

DIAGNOSTIC_TEST

Histopathology and Immunohistochemistry

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.

Locations (1)

Dr. Madhumita Premkumar
Sector-12, Chandigarh, India