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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Enrolling

Conditions: Cardiac Disease; Cirrhosis, Liver; Cirrhotic Cardiomyopathy

Treatments: Diagnostic Test: Histopathology and Immunohistochemistry; Device: Echocardiographic assessment

Study type: Observational

Funder types: Other

Identifiers

NCT06095466

INT/IEC/2023/SPL-963

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Cirrhotic cardiomyopathy

Description:

Cirrhotic cardiomyopathy, among a broad spectrum of cardiac complications in cirrhosis, is characterized by systolic and diastolic cardiac dysfunction and electrocardiographic changes. However, it is seen more in NASH related cirrhotic patients, who have an additional risk of developing cardiac complications. Cirrhosis contributes to a including cirrhotic cardiomyopathy owing to various pathological conditions interlinked at the cellular and molecular level. A hyperdynamic circulatory state caused due to excessive release of vasodilators in a pro-inflammatory condition of cirrhosis, along with negative-inotropic pathways contributes to the development of a compromised cardiac function. Electrocardiography, 2D echocardiography with tissue Doppler or speckle tracking are the routine diagnostic tests used to diagnose CCM.

Treatment:

Diagnostic Test: Histopathology and Immunohistochemistry

Device: Echocardiographic assessment