Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06095466

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

Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2023-10-23

150

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cirrhotic cardiomyopathy is a heart condition linked to cirrhosis that increases risks of serious complications like hepatorenal syndrome, refractory ascites, and poor response to stressors such as sepsis or bleeding. This condition leads to increased health problems and mortality. The study focuses on left ventricular diastolic dysfunction (LVDD), which is associated with worse outcomes after liver transplantation and procedures like trans-jugular intrahepatic portosystemic shunt (TIPS). Researchers aim to better understand how LVDD and cirrhotic cardiomyopathy affect critically ill patients with cirrhosis. The study involves screening critically ill cirrhotic patients admitted to the intensive care unit using point-of-care echocardiography, electrocardiography, and cardiorenal biomarker tests to identify cirrhotic cardiomyopathy and evaluate cardiac function. For patients who do not survive, researchers will perform ultrasound-guided myocardial biopsies to examine heart tissue for inflammation and fibrosis. Routine diagnostic tests include 2D echocardiography with tissue Doppler or speckle tracking and electrocardiography. Participants will undergo echocardiographic assessments including M mode, cross-sectional, and Doppler examinations. Researchers will measure aspects like heart wall thickness and ventricle size while patients lie in the left lateral position. They will also collect biomarker data and cardiac histology from consenting deceased patients. The main measure is the prevalence of cirrhotic cardiomyopathy at enrollment, with additional assessments of cardiac dysfunction severity and tissue changes. The study monitors these outcomes to better understand heart complications in critically ill cirrhotic patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 65 years
  • Diagnosed with cirrhosis by clinical, biochemical, histological, or ultrasound methods
  • Critically ill patients admitted to the Liver Intensive Care Unit
Not Eligible

You will not qualify if you...

  • Age over 65 years
  • Chronic renal disease
  • Pregnancy or peripartum cardiomyopathy
  • Valvular heart disease
  • Sick sinus syndrome or presence of pacemaker
  • Transjugular intrahepatic porto systemic shunt (TIPS) insertion
  • Hepatocellular carcinoma
  • Anemia with hemoglobin less than 8 gm/dl in females and less than 9 gm/dl in males at assessment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At enrollment

Participants undergo point-of-care echocardiography, electrocardiography, and cardiorenal biomarker tests to assess cardiac function and presence of cirrhotic cardiomyopathy.

1 visit (in-person)

Long-term Monitoring

Duration - At the time of demise

Participants who do not survive may undergo ultrasound-guided myocardial biopsy for cardiac histology assessment to evaluate inflammation and fibrosis.

1 additional biopsy procedure if applicable

Trial Site Locations

Total: 1 location

1

Dr. Madhumita Premkumar

Sector-12, Chandigarh, India, 160012

Actively Recruiting

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Research Team

M

Madhumita Premkumar

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Left Ventricular Diastolic Dysfunction is Associated with Renal Dysfunction, Poor Survival and Low Health Related Quality of Life in Cirrhosis.

Madhumita Premkumar, Devaraja Devurgowda, Tanmay Vyas...

https://pubmed.ncbi.nlm.nih.gov/31360025