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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL181174 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cirrhosis-related outcomes | Clinical ascites, hepatic encephalopathy, portal hypertension related bleeding, hepatorenal syndrome, portopulmonary hypertension, hepatopulmonary syndrome | 1 or more years of follow up (up to 4 years) |
| Adverse Cardiac Outcomes | Myocardial infarction, Unstable angina, Stable angina, Coronary revascularization, Heart failure, Arrhythmia | 1 or more years of follow up (up to 4 years) |
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Inclusion Criteria:
Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:
Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C
Age ≥ 18 years
Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics
Willing to adhere to study protocol
Able to provide written informed consent
Exclusion Criteria:
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Study population will be identified through clinic referrals and inpatient evaluations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manhal Izzy, MD | Contact | 615-875-6540 | manhal.izzy@vumc.org | |
| Deepak Gupta, MD | Contact | d.gupta@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Manhal Izzy, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31342529 | Background | Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11. | |
| 37688403 | Background | Kajal K, Premkumar M, Izzy M, Kulkarni AV, Duseja AK, Divyaveer S, Loganathan S, Sihag B, Gupta A, Bahl A, Rathi S, Taneja S, De A, Verma N, Sharma N, Kaur H, Zohmangaihi D, Kumar V, Bhujade H, Chaluvashetty SB, Kalra N. Cirrhotic cardiomyopathy influences clinical outcomes and enhances performance of conventional risk prediction models in acute-on-chronic liver failure with severe sepsis. Aliment Pharmacol Ther. 2023 Nov;58(9):903-919. doi: 10.1111/apt.17695. Epub 2023 Sep 9. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blood specimens may be retained.
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| 39185907 | Background | Myers S, Gupta DK, Izzy M. The clinical relevance of the new criteria for cirrhotic cardiomyopathy and future directions. Liver Transpl. 2025 Apr 1;31(4):521-530. doi: 10.1097/LVT.0000000000000458. Epub 2024 Aug 27. |