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, 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

This trial does not accept healthy volunteers

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 population

Study population will be identified through clinic referrals and inpatient evaluations.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

440 Participants
are grouped into 1 trial group
Group A: Decompensated cirrhosis

Trial outcomes

Primary outcomes

1

All-Cause Mortality

Death from any cause occurring during the follow-up period. Mortality status will be ascertained through review of medical records.

Time frame
Up to 4 years

Secondary outcomes

Other outcomes

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