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, 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.
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
Sponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator