[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549277":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Simvastatin + Carvedilol-arm","EXPERIMENTAL","* Simvastatin fixed dose of 20 mg per day\n* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate\n* Standard Medical Therapy",[13,14],"Drug: Simvastatin 20mg","Drug: Carvedilol 3.125 mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Active Comparator: Carvedilol arm","ACTIVE_COMPARATOR","* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate\n* Standard Medical Therapy",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Simvastatin 20mg","Simvastatin fixed dose of 20 mg per day",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Carvedilol 3.125 mg","Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Dr Madhumita Premkumar, DM","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","7087003409","drmadhumitap@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"PGIMER, Department of Hepatology","RECRUITING","Chandigarh","160012","India","IN",{"type":49,"coordinates":50},"Point",[51,52],76.7884,30.73629,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":26,"email":58},"Prerna Sharma, MSc","+911722754777","hepatology.mpk@gmail.com",{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Madhumita Premkumar","ADDITIONAL PROFESSOR",[63],{"name":64,"class":65},"Indian Council of Medical Research","OTHER_GOV","100549277","carvedilol--simvastatin-vs-carvedilol-alone-for-cirrhosis-and-cirrhotic-cardiomyopathy-and-impact-on-hepatic-decompensation-and-survival-100549277",false,"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.)","ALL","18 Years","65 Years",{"count":78,"type":79},260,"ESTIMATED","INTERVENTIONAL",[82],"NA","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).",[85,86,87,88,89],"Decompensated Cirrhosis","Cirrhotic Cardiomyopathy","Cirrhosis, Liver","Left Ventricular Diastolic Dysfunction","Acute Kidney Injury",[85,86,91,92],"Left ventricular diastolic dysfunction","Acute kidney injury","2025-06-05",{"date":95,"type":96},"2025-06-08","ACTUAL",{"date":98,"type":79},"2025-06-10",{"date":100,"type":79},"2028-02",{"name":5,"class":6},1]