Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, > mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator

End-stage heart, kidney, or lung disease

Pulmonary Arterial Hypertension

Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

440 Participants
are grouped into 1 trial group

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator