Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Conditions

• Cirrhotic Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

First listed

Jun 18, 2026

Start date

Jan 20, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

440 participants (estimated)

Arms

• Arm: 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

• Manhal Izzy, MD
  615-875-6540
  [email protected]
• Deepak Gupta, MD
  [email protected]

Locations (2)

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