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Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Recruitingn/aAges 18 Years - anyAllVanderbilt University Medical Center
NCT07658222 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C 3. Age ≥ 18 years 4. Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics 5. Willing to adhere to study protocol 6. Able to provide written informed consent Exclusion Criteria: 1. Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, \> mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator 2. End-stage heart, kidney, or lung disease 3. Pulmonary Arterial Hypertension 4. Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures) 5. Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D) 6. Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing 7. Pregnancy 8. Prior TIPS
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What it tests

  • Not listed
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Where

2 sites
Vanderbilt University Medical Center
Nashville, United States
UT Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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