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Clinical Trials in India / NCT06095466
Recruiting Observational

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

NCT06095466 · tracked via the Priya Life Science India tracker
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Phase
Observational
Started
2023-07-15
Last updated
2023-10-23

Condition(s) studied

Cirrhotic CardiomyopathyCirrhosis, LiverCardiac Disease

Investigational drug(s) / intervention(s)

Echocardiographic assessmentHistopathology and Immunohistochemistry

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.

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dr. Madhumita Premkumar Sector-12 Chandigarh Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06095466 on ClinicalTrials.gov ↗ ← All trials in India