Cirrhotic Cardiomyopathy in Adults: A Prospective multicenter look

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study of adults with decompensated cirrhosis to characterize the prevalence and clinical impact of cirrhotic cardiomyopathy (CCM). It will examine risk factors, associations with cirrhosis-related outcomes, and the potential role of circulating bile acids in CCM development. Researchers will use echocardiography to identify subclinical heart dysfunction and follow participants longitudinally to assess outcomes and survival. The study is conducted at Vanderbilt University Medical Center and UT Southwestern, with collaboration from NIH/NHLBI. No intervention is being tested; the work is hypothesis-generating and aims to inform future research and care strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:

   * portal hypertension-related bleeding,
   * hepatic encephalopathy, and/or
   * clinical ascites.
2. Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C
3. Age ≥ 18 years
4. Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics
5. Willing to adhere to study protocol
6. Able to provide written informed consent

Exclusion Criteria:

1. Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, \> mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator
2. End-stage heart, kidney, or lung disease
3. Pulmonary Arterial Hypertension
4. Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)
5. Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D)
6. Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing
7. Pregnancy
8. Prior TIPS

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Manhal Izzy, MD — Vanderbilt University Medical Center
• Study coordinator: Manhal Izzy, MD
• Email: manhal.izzy@vumc.org
• Phone: 615-875-6540

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Carvedilol plus simvastatin versus carvedilol alone for cirrhosis-related heart dysfunction

  This trial will test whether adding simvastatin to carvedilol helps adults with cirrhosis and cirrhotic cardiomyopathy reduce liver decompensation and improve survival.

  Recruiting Post Graduate Institute of Medical Education and Research, Chandigarh · Chandigarh · NCT06431919

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.