[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641193":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":24,"responsibleParty":62,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":10,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Decompensated cirrhosis",null,"Patients with cirrhosis and current or prior occurrence of one or more of the following:\n\n• 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\u002For • clinical ascites (i.e., fluid build up in the abdomen).\n\nThe cohort will then be analyzed based on the presence of cirrhotic cardiomyopathy.",[13],{"name":14,"affiliation":5,"role":15},"Manhal Izzy, MD","PRINCIPAL_INVESTIGATOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","615-875-6540","manhal.izzy@vumc.org",{"name":22,"role":18,"phone":10,"phoneExt":10,"email":23},"Deepak Gupta, MD","d.gupta@vumc.org",[25,45],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Nashville","Tennessee","37203","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-86.78444,36.16589,{"lat":36,"lon":35},[39,42,43],{"name":40,"role":18,"phone":41,"phoneExt":10,"email":20},"Manhal Izzy","MD",{"name":14,"role":15,"phone":10,"phoneExt":10,"email":10},{"name":22,"role":44,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":30,"countryCode":31,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"UT Southwestern Medical Center","Dallas","Texas","75390",{"type":33,"coordinates":51},[52,53],-96.80667,32.78306,{"lat":53,"lon":52},[56,60],{"name":57,"role":18,"phone":58,"phoneExt":10,"email":59},"Lisa VanWagner,, MD","214-648-3111","Lisa.Vanwagner@UTSouthwestern.edu",{"name":61,"role":44,"phone":10,"phoneExt":10,"email":10},"Lisa Vanwagner, MD",{"type":15,"investigatorFullName":40,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Professor",[65,68],{"name":66,"class":67},"National Institutes of Health (NIH)","NIH",{"name":69,"class":67},"National Heart, Lung, and Blood Institute (NHLBI)","100641193","prospective-investigation-of-cirrhotic-cardiomyopathy-in-humans-100641193",false,"NCT07658222","Prospective Investigation of Cirrhotic Cardiomyopathy in Humans","PITCH","Inclusion Criteria:\n\n1. Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:\n\n   * portal hypertension-related bleeding,\n   * hepatic encephalopathy, and\u002For\n   * clinical ascites.\n2. Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C\n3. Age ≥ 18 years\n4. Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics\n5. Willing to adhere to study protocol\n6. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, \\> mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator\n2. End-stage heart, kidney, or lung disease\n3. Pulmonary Arterial Hypertension\n4. Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)\n5. Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D)\n6. Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing\n7. Pregnancy\n8. Prior TIPS","ALL","18 Years",{"count":80,"type":81},440,"ESTIMATED","OBSERVATIONAL","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.",[85],"Cirrhotic Cardiomyopathy",[87,88],"Cirrhotic cardiomyopathy","Cirrhosis","2026-07-17",{"date":91,"type":92},"2026-07-21","ACTUAL",{"date":94,"type":92},"2026-01-20",{"date":96,"type":81},"2030-06-30",{"name":5,"class":6},2]