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NCT Number: NCT06095466

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

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.

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Key information

Conditions

Cirrhotic Cardiomyopathy Cardiac Disease Cardiovascular Diseases Cirrhosis, Liver Digestive System Diseases Fibrosis Heart Diseases Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Madhumita Premkumar

Sector-12, Chandigarh, 160012, India

Location status: Recruiting

Location contact

Dr. Madhumita Premkumar, MD

CONTACT

[email protected]

About this study

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.

In this project the investigators will screen critically ill patients with cirrhosis admitted to the intensive care unit for presence of cirrhotic cardiomyopathy and perform point-of-care echocardiography, electrocardiography, and cardiorenal biomarker tests for determination of outcomes in CCM. In patients who do not survive, the cardiac histology will be assessed by ultrasound guided myocardial biopsy to assess degree of inflammation and fibrosis in CCM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: At Enrollment

    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.

Secondary outcomes

  1. Determine severity of cardiac dysfunction in critically ill patients with cirrhosis

    Time frame: At Enrollment

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

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

    Time frame: At Enrollment

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

  3. Determine the cardiac histology changes in critically ill patients with cirrhosis

    Time frame: At the time of demise

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

Study contacts

Contact information is provided by the study sponsor or research team.

Madhumita Premkumar

CONTACT

[email protected]

01722754777

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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