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Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C

• Age ≥ 18 years

• Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics

• Willing to adhere to study protocol

• Able to provide written informed consent

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Manhal Izzy, MD
manhal.izzy@vumc.org
615-875-6540
Backup
Deepak Gupta, MD
d.gupta@vumc.org
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 440
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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