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
This trial does not accept healthy volunteersQualifiers
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 population
Study population will be identified through clinic referrals and inpatient evaluations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Cirrhosis-related outcomes
Clinical ascites, hepatic encephalopathy, portal hypertension related bleeding, hepatorenal syndrome, portopulmonary hypertension, hepatopulmonary syndrome
Adverse Cardiac Outcomes
Myocardial infarction, Unstable angina, Stable angina, Coronary revascularization, Heart failure, Arrhythmia
Sponsors and contacts
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Vanderbilt University Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator