Cirrhotic Cardiomyopathy
Conditions
Keywords
Cirrhotic cardiomyopathy, Cirrhosis
Brief summary
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.
Detailed description
Cirrhotic cardiomyopathy (CCM) is a recognized but understudied and not well understood complication of cirrhosis. CCM is defined as subclinical (i.e., silent) heart dysfunction identified by echocardiography in patients with cirrhosis in the absence of other heart diseases such as significant coronary artery, valvular, or pericardial disease. Initial small studies indicate that CCM is common and it warrants larger prospective study in humans to address unanswered questions highly relevant to clinical care. These include 1) what are the associations between CCM and cirrhosis-related outcomes, adverse cardiac events, and survival 2) what clinical factors increase the risk for CCM, and 3) do bile acids levels, which are produced by the liver, in the blood associate with features of CCM.
Interventions
None listed
Sponsors
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | Up to 4 years | Death from any cause occurring during the follow-up period. Mortality status will be ascertained through review of medical records. |
Countries
United States
Contacts
CONTACTManhal Izzy, MD
CONTACTDeepak Gupta, MD
PRINCIPAL_INVESTIGATORManhal Izzy, MD
Vanderbilt University Medical Center
Outcome results
None listed