Prospective Investigation of Cirrhotic Cardiomyopathy in Humans
Purpose
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.
Condition
- Cirrhotic Cardiomyopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cirrhotic cardiomyopathy | Subjects should have decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following: • portal hypertension-related bleeding (a type of bleeding from the gut in patients with cirrhosis),• hepatic encephalopathy (i.e., alteration in mental status due to cirrhosis), and/or • clinical ascites (i.e., fluid build up in the abdomen). The cohort will then be analyzed based on the presence of cirrhotic cardiomyopathy. |
Recruiting Locations
Nashville, Tennessee 37203
Dallas, Texas 75390
More Details
- Status
- Recruiting
- Sponsor
- Vanderbilt University Medical Center
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 bi le acids levels, which are produced by the liver, in the blood associate with features of CCM. In this study, we conduct the first US based prospective investigation of CCM in humans with decompensated cirrhosis.