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Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Who can join

Ages 18 and older · All sexes

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

About the study

Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but understudied despite recent retrospective data suggesting it may be common, affecting one in three patients with decompensated cirrhosis, and associated with significantly increased risk of death and adverse hepatic and cardiac events. Moreover, evidence from preclinical models and children suggest elevated bile acids in the blood may contribute to CCM, but data from adults with cirrhosis are scarce. Therefore, this study will be the first contemporary prospective multicenter investigation of CCM in adults with cirrhosis in the United States. The study will characterize risk factors for CCM, determine its impact on clinical outcomes, and investigate the contribution of circulating bile acids to disease development.

Sponsor: Vanderbilt University Medical Center · Participants: 440 · Started: Jan 20, 2026

Contact the study team

• Manhal Izzy, MD · Phone: 615-875-6540

Official record on ClinicalTrials.gov — NCT07658222

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.