[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cirrhotic-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cirrhotic-cardiomyopathy":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,76,106,136,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":19,"type":20},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, 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.",[24],"Cirrhotic Cardiomyopathy",[26,27],"Cirrhotic cardiomyopathy","Cirrhosis","RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-18","ACTUAL",{"date":34,"type":32},"2026-01-20",{"date":36,"type":20},"2030-06-30",{"name":38,"class":39},"Vanderbilt University Medical Center","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100617716","phase-4-dice-study--diastolic-improvement-with-carvedilol--empagliflozin-in-patients-with-cirrhosis-100617716","NCT07322237","DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis","Empagliflozin + Carvedilol vs. Carvedilol Alone for Patients With Cirrhosis and Left Ventricular Diastolic Dysfunction and Impact on Hepatic Decompensation and Survival: A Double-Blind Placebo-Controlled Randomized Controlled Trial","DICE","Inclusion criteria\n\n* Age range of 18-65 years\n* Cirrhosis as diagnosed by histology or clinical laboratory and USG findings\n* LVDD (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion criteria\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* History of urinary tract \u002Fgenital infections in last 3 months\n* Patient on treatment with statin (one month before the study)\n* Advanced Cirrhosis (MELD\\>20)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker valvular heart disease\n* Cardiac rhythm disorder Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6months.","65 Years",{"count":51,"type":20},400,"INTERVENTIONAL",[54],"PHASE4","1. This proposed double-blind placebo controlled randomized controlled trial incorporates recent advances in management of heart failure and portal hypertension using the SGLT-2 inhibitor i.e. EMPAGLIFLOZIN. The drug has been found to be useful in large trials on heart failure with preserved ejection fraction in the general population with improvement in MASLD progression, with improvement in body weight and hepatic steatosis but no change in liver fibrosis.\n2. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the development and progression of heart failure in patients with type 2 diabetes and in those with heart failure and a reduced and preserved ejection fraction. In patients with cirrhosis safety of empagliflozin in a dose of 10 mg has been demonstrated.\n3. Prevention of decompensation related events in cirrhosis is the key endpoint of any liver-directed therapy as the median survival in the compensated state exceeds 10 years but median survival in the decompensated state approximates 1.5 years. Previous data has demonstrated the risk of hepatic decompensation acute kidney injury and poor survival in patients with cirrhosis and heart failure with preserved ejection fraction (HFpEF) i.e. LVDD a large subset of whom meet criteria for CCM.",[24,57,58,27],"Empagliflozin","Cardiometabolic Risk Factors",[60,61,62,63,64,65],"Empagliflozin in cirrhosis","Carvedilol in Cirrhosis","SGLT-2 inhibitor","Ascites","Diastolic heart failure","heart failure with preserved ejection fraction","2026-05-13",{"date":68,"type":32},"2026-05-14",{"date":70,"type":32},"2026-04-01",{"date":72,"type":20},"2029-06-30",{"name":74,"class":39},"Post Graduate Institute of Medical Education and Research, Chandigarh",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100631554","heart-problems-in-children-with-chronic-liver-disease-100631554","NCT07502196","Heart Problems in Children With Chronic Liver Disease","Assessment of Cardiac Problems in Children With Chronic Liver Disease","Inclusion Criteria:\n\n* All patients below 18 years who diagnosed with chronic liver disease.\n\nExclusion Criteria:\n\n* All patients known to have congenital heart disease or previous cardiac disease.","17 Years",{"count":85,"type":20},60,"Chronic liver disease (CLD) in children can sometimes lead to complications in other parts of the body, including the heart. The primary purpose of this observational study is to assess the presence and type of cardiac problems in children who have been diagnosed with chronic liver disease.\n\nResearchers will observe children under the age of 18 who are receiving care at the gastroenterology and hepatology unit at Assiut University Children Hospital. Participants will undergo standard medical evaluations to check both their liver and heart health.\n\nThese evaluations include:\n\n* A detailed medical history and thorough physical examination\n* Routine blood tests to check liver function, kidney function, coagulation, and electrolytes\n* Abdominal imaging, such as an ultrasound, to look at the liver.\n* An electrocardiogram (ECG) to check the heart's electrical activity and rhythm, including measuring the QTc interval.\n* An echocardiogram to look at the structure of the heart and check how well its chambers and valves are functioning.\n\nThe study aims to identify specific heart conditions that can be associated with severe liver disease, such as portopulmonary hypertension, cirrhotic cardiomyopathy (changes in the heart muscle's function), and electrical repolarization abnormalities. Children who already have known congenital heart disease or a history of other heart problems will not be included in the study.",[88,89,90,91,24],"Chronic Liver Disease (CLD)","Liver Cirrhosis","Cardiac Abnormalities","Portopulmonary Hypertension",[93,89,94,91,24,95],"Chronic Liver Disease","Cardiac Problems","Cardiac Repolarization Abnormalities","NOT_YET_RECRUITING","2026-03-25",{"date":99,"type":32},"2026-03-30",{"date":101,"type":20},"2026-04",{"date":103,"type":20},"2027-05",{"name":105,"class":39},"Assiut University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":114,"targetDuration":4,"studyType":52,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":75},"100614980","echocardiography-guided-cirrhosis-and-liver-failure-intensive-care-protocol-sepsis-100614980","NCT07286643","Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis","Point-of-care Echocardiogram (POCUS) Guided Resuscitation Versus Conventional Goal- Directed Therapy in the Management of Cirrhosis With Severe Sepsis or Septic Shock: A Randomised Controlled Trial","ECLIPSE-I","Inclusion Criteria:\n\n1. Critically ill patient with cirrhosis of any etiology\n2. Sepsis-related Hypotension (MAP \\\u003C65mmHg or SBP \\\u003C90mmHg)\n3. 18-65 yrs of age -\n\nExclusion Criteria:\n\n1. Already on vasopressors\u002Finotropes\n2. Severe pre-existing cardiopulmonary disease like porto-pulmonary hypertension (PPH), known coronary artery disease, congenital or valvular heart disease, prosthetic cardiac valves, dilated or restrictive cardiomyopathy.\n3. Poor chest wall window due to left pleural effusion, left pneumothorax, small intercostal spaces that restrict performance of a POCUS.\n4. Active bleeding like variceal bleed\n5. Cerebrovascular events\n6. Chronic renal disease - End Stage Renal Disease (ESRD)\u002F patient on renal replacement therapy\n7. Admission to ICU following liver transplantation, burns, cardiac surgery\n8. Previous transjugular intra hepatic portosystemic shunt (TIPS),\n9. Hepatocellular carcinoma\n10. Pregnant or lactating women\n11. Informed consent refused by patient or attendants\n12. Active COVID-19 infection",{"count":115,"type":20},140,[117],"NA","* Point-of-care echocardiography is used to guide septic shock resuscitation in patients with severe sepsis in the intensive care unit (ICU), but without systematic evidence for efficacy in critically patients with Cirrhosis and Severe Sepsis.\n* Due to portal hypertension, these patients have a hyperdynamic circulation, increased capillary permeability, splanchnic arteriolar vasodilation, reduced effective circulating blood volume and may have latent cirrhotic cardiomyopathy (CCM).\n* Hence assessment of volume status and cardiac reserve using conventional central venous pressure (CVP) or mean arterial pressure (MAP) remains difficult.\n\nNovelty:\n\n* In two recent trials, the role of 5% albumin vs PlasmalyteTM (FRISC study)(1) and 20% albumin vs. PlasmalyteTM (ALPS study) (2) were reported as the primary resuscitation fluid. Neither trial showed a clear long term survival benefit of albumin over balanced salt solution (BSS). In fact, the ALPS trial reported that there was increased risk of pulmonary edema with use of 20% albumin as fluid resuscitation.\n* A major limitation of such trial data is that the focus is on choice of fluid rather than looking at hemodynamic goals of resuscitation, resulting in protocolized overzealous fluid administration.\n* This may result in albumin-related pulmonary edema, and precipitation of overt heart failure in patients with silent CCM.\n* POC-Echo-based fluid resuscitation can prevent pulmonary edema and consequently respiratory failure, while ensuring renal and tissue perfusion.\n* It is unclear if choice of fluid or appropriate targets of resuscitation drive the survival benefit in the intensive care management of cirrhosis with severe sepsis.\n\nObjectives:\n\n* The investigators will conduct an ICU based randomised controlled feasibility trial comparing two measures of resuscitation: Echocardiography (ECHO) Guided septic shock resuscitation vs. a modified Goal-Directed Fluid Therapy (GDT) as recommended by sepsis guidelines which use protocol fluids.\n* The study will validate the role of POC-Echo parameters as volume assessment tools (cardiac index, systemic vascular resistance index) to determine endpoints of fluid resuscitation and need for vasopressors.\n* Lastly, the study aims to determine the presence of CCM in this population, and its impact on clinical outcomes.\n\nMethods POC-ECHO will be done within 1 hours of admission to the liver ICU and at 24h, 48 h and 72 hours in patients with cirrhosis with systolic blood pressure of \\\u003C90 mmHg or a mean arterial pressure \\\u003C65 mmHg. Resuscitation target is maintenance of MAP ≥65 mmHg with use of fluids and\u002For vasopressors. Clinical, cardiac biomarkers, and survival data based on resuscitation fluids will be prospectively collected. CCM will be defined as per CCM Consortium (2020) criteria.\n\nExpected outcome.\n\nThe key questions to be answered in the resuscitation of critically ill patients with cirrhosis and sepsis induced hypotension are:\n\n1. What should be best method of ensuring adequate fluid resuscitation i.e. fluid resuscitation protocol?\n2. Which measurable clinical parameter can be used to determine adequacy of fluid resuscitation, and as a predictor of mortality outcomes at 7 and 28 days?\n3. Whether early fluid resuscitation translates into better clinical outcome in decreasing duration of hospital and intensive care unit (ICU) stay, prevention of AKI and prevention of secondary sepsis?",[120,24,121],"Cirrhosis, Liver","Septic Shock",[123,124,125,126,127],"echocardiography","cardiac output monitoring","hemodynamics","fluid resuscitation.","POCUS","2025-12-13",{"date":130,"type":32},"2025-12-16",{"date":132,"type":20},"2026-01-01",{"date":134,"type":20},"2028-12-30",{"name":74,"class":39},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":144,"targetDuration":4,"studyType":52,"phases":146,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":75},"100549277","carvedilol--simvastatin-vs-carvedilol-alone-for-cirrhosis-and-cirrhotic-cardiomyopathy-and-impact-on-hepatic-decompensation-and-survival-100549277","NCT06431919","Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival","Carvedilol + Simvastatin vs. Carvedilol Alone for Chronic Liver Disease and Cirrhotic Cardiomyopathy and Its Impact on Hepatic Decompensation and Survival; a Double-blind Randomized Controlled Trial","CIRROSTAT","Inclusion Criteria:\n\n* Age range of 18-65 years\n* Compensated cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,\n* CCM (with EF\\>50%) on 2D echocardiography with TDI\n* Written informed consent.\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Serum Creatinine\\>2 mg\u002Fdl\n* Patient previously treated with statin (one month before the study)\n* Contraindications to statins\n* Advanced Cirrhosis (CTP score\\>9)\n* Coronary artery disease\n* Sick sinus syndrome\u002F Pacemaker, valvular heart disease\n* Cardiac rhythm disorder, Peripartum cardiomyopathy\n* Portopulmonary hypertension\u002F hepatopulmonary syndrome\n* Transjugular intrahepatic portosystemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Pregnancy or lactation\n* Patients with HIV or retroviral therapy\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males\n* Acute variceal bleeding in last 6 months.\n* Need for medications, metabolized by CYP3A4(such as amlodipine, verapamil, fenofibrate azole antibiotics, protease inhibitors etc.)",{"count":145,"type":20},260,[117],"Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.\n\nRationale:\n\nCirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including ascites, variceal bleeding, acute kidney injury, and susceptibility to infections. CCM, present in 30-70% of patients, is characterized by structural and functional abnormalities in the heart, and is associated with progression of cirrhosis, impaired quality of life and poor survival. Statins play a crucial role in reducing proatherogenic LDL cholesterol levels, making them a cornerstone in managing diabetes and cardiovascular diseases (CVDs) with the aim of decreasing or reversing atherosclerosis. This trial aims to evaluate the impact and safety of simvastatin in cirrhotic cardiomyopathy.\n\nNovelty: Simvastatin might be of special value in diastolic dysfunction through its hemodynamic and functional effects on LV remodeling and improve portal hemodynamics through the pleotropic effects of lipophilic statins.\n\nObjectives:\n\nThe primary objective is to assess the combined effects of carvedilol and simvastatin in managing CCM vs carvedilol alone for a composite outcome to prevent decompensation and reduce all-cause mortality. We will comprehensively evaluate cardiac function, decompensation events and survival based on impact of simvastatin over the standard betablocker carvedilol.\n\nMethods:\n\nThis is a double-blinded randomized placebo-controlled trial involving patients diagnosed with CCM. Clinical data, including cardiac imaging, cardiac biomarkers, and survival outcomes, will be assessed for either group.\n\nExpected Outcome:\n\nThe investigators anticipate that the synergistic use of simvastatin and carvedilol will effectively reduce portal pressure, improve portal haemodynamic, and enhance cardiac remodelling. Successful reversal of LVDD can potentially prevent clinical events such as ascites, encephalopathy, and acute kidney injury (AKI).",[149,24,120,150,151],"Decompensated Cirrhosis","Left Ventricular Diastolic Dysfunction","Acute Kidney Injury",[149,24,153,154],"Left ventricular diastolic dysfunction","Acute kidney injury","2025-06-05",{"date":157,"type":32},"2025-06-08",{"date":159,"type":20},"2025-06-10",{"date":161,"type":20},"2028-02",{"name":74,"class":39},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":75},"100523421","cirrhotic-cardiomyopathy-based-on-point-of-care-echocardiography-biomarkers-and-histology-100523421","NCT06095466","Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology","Diagnosis and Pathogenetic Mechanisms in Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology","Inclusion Criteria:\n\n* Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following:\n\n  * Age range of 18-65 years\n  * Cirrhosis with critical illness admitted to the Liver Intensive Care Unit\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Chronic renal disease\n* Pregnancy and peripartum cardiomyopathy\n* Valvular heart disease\n* Sick sinus syndrome\u002F Pacemaker\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Anemia Hb \\\u003C 8gm\u002Fdl in females, and \\\u003C 9 gm\u002Fdl in males at the time of assessment",{"count":171,"type":20},150,"Cirrhotic cardiomyopathy is associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E\u002Fe' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre.",[24,120,174],"Cardiac Disease","2023-10-18",{"date":177,"type":32},"2023-10-23",{"date":179,"type":32},"2023-07-15",{"date":181,"type":20},"2026-10-15",{"name":74,"class":39}]