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, we are conducting the first contemporary prospective multi-center investigation of CCM in adults in the USA to define CCM risk factors and impact on outcomes while deepening understanding of the role of bile acids in development of this disease.

Key Dates

Start date

Jan 20, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

440 participants (estimated)

Arms

• Arm: Cirrhotic cardiomyopathy
  Subjects should have decompensated cirrhosis, defined as cirrhosis with 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

Cirrhosis-related outcomes [ Time Frame: 1 or more years of follow up (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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