Recruiting

Cirrhotic Cardiomyopathy

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07658222

Conditions

Cirrhotic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Cirrhotic Cardiomyopathy

Study ID

NCT07658222

Start date

Jan 20, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

440 participants

Anticipated

Interventions and Outcome Measures

Arms

Decompensated cirrhosis

Patients with cirrhosis and current or prior occurrence of one or more of the following:

• portal hypertension-related bleeding (a type of bleeding from the gut in patients with cirrhosis),• hepatic encephalopathy (i.e., alteration in mental status due to cirrhosis), and/or • clinical ascites (i.e., fluid build up in the abdomen).

The cohort will then be analyzed based on the presence of cirrhotic cardiomyopathy.

Primary outcome measure

  • All-Cause Mortality [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Manhal Izzy, MD

615-875-6540manhal.izzy@vumc.org

Deepak Gupta, MD

d.gupta@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Manhal Izzy

MDmanhal.izzy@vumc.org

Principal Investigator:

Manhal Izzy, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Lisa VanWagner,, MD

214-648-3111Lisa.Vanwagner@UTSouthwestern.edu

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Cirrhotic cardiomyopathy
  • Cirrhosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-07-21.