Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06386094

Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease

Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2025-01-29

150

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the connection between non-alcoholic fatty liver disease (NAFLD), also called metabolic dysfunction-associated steatotic liver disease (MASLD), and cardiac dysfunction. Conditions like cirrhotic cardiomyopathy, coronary artery disease, and heart failure are being studied due to their links with NAFLD. The study aims to develop a model for cardiac dysfunction in patients with NAFLD, as heart problems are a significant cause of mortality in this group. Participants will undergo various non-invasive tests such as APRI, FIB-4, FAST scan, and vibration-controlled transient elastography (Fibroscan) to evaluate liver status. Liver biopsy may be performed if clinically indicated. Echocardiographic assessments using M mode, cross-sectional, and Doppler techniques will examine heart structure and function to detect abnormalities. Diagnosis of NAFLD will be based on medical history, physical exams, lab tests, imaging, and liver biopsy when available. Throughout the study, researchers will collect data on heart function and liver disease severity, including echocardiographic measurements and myocardial and perfusion abnormalities. The main goal is to determine how common cardiac dysfunction is in NAFLD patients. Additional outcomes include tracking mortality rates and cardiac event-related deaths up to 12 months after enrollment. Participants will be monitored using non-invasive assessments and clinical evaluations during the study period.

CONDITIONS

Brief Title

Cardiac Dysfunction in Patients with Fatty Liver Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age range of 18-65 years
  • Diagnosis of metabolic dysfunction associated steatotic liver disease by histology, clinical evaluation, lab tests, non-invasive tests, ultrasound, or vibration controlled transient elastography (VCTE)
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 enrolment

Participants undergo echocardiographic assessments and other non-invasive tests to evaluate cardiac function and assess liver disease status.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months after enrolment

Participants are monitored for cardiac events and overall health outcomes related to metabolic dysfunction associated steatotic liver disease over 12 months.

Periodic follow-up visits

Trial Site Locations

Total: 1 location

1

Dr. Madhumita Premkumar

Chandigarh, 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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Frequently Asked Questions

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Published Research Related To This Trial

Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes.

Zobair M Younossi, Aaron B Koenig, Dinan Abdelatif...

https://pubmed.ncbi.nlm.nih.gov/26707365