[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617716":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":38,"responsibleParty":56,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":83,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Empagliflozin + Carvedilol-arm","ACTIVE_COMPARATOR","Experimental: Empagliflozin + Carvedilol-arm\n\n* Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes for 1 year from randomization\n* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate\n* Standard Medical Therapy for liver disease as per clinician decision",[13],"Drug: Empagliflozin + Carvedilol",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Comparator: Carvedilol arm","* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo administered once daily.\n* Standard Medical Therapy prescribed as per clinician decision",[18],"Drug: Carvedilol",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Empagliflozin + Carvedilol","Patient Recruitment:\n\nThe study participants are all cirrhosis patients receiving treatment at PGIMER Chandigarh. Eligible participants meeting LVDD criteria per the CCM Consortium 2020 consensus.\n\nCarvedilol Dosing protocol in this study Patients will be given carvedilol in a starting dose of 3.125 mg twice daily. The dose will be titrated weekly to achieve a target heart rate of 50-60\u002F min taking care that side effects such as hypotension bronchospasm excessive bradycardia are not seen. The maximum dosage allowed as per prior trial data is 25 mg per day.\n\nEmpagliflozin Dosing protocol in this Study:\n\n• All patients will receive a standard dose of Empagliflozin fixed dose of 10 mg per day in patients with or without diabetes.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Carvedilol","* Carvedilol: Starting dose of 3.125 mg twice daily targeted upwards q 7 days to achieve target heart rate 10 mg placebo pill\n* Standard Medical Therapy",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Madhumita Premkumar, MD DM","CONTACT","01722754777","drmadhumitap@gmail.com",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":25},"Madumita Premkumar",[39],{"facility":40,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"PGIMER Chandigarh","RECRUITING","Chandigarh","160012","India","IN",{"type":47,"coordinates":48},"Point",[49,50],76.7884,30.73629,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":34,"phoneExt":25,"email":55},"Prerna Sharma","hepatology.mpk@gmail.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Madhumita Premkumar","Additional Professor","100617716","phase-4-dice-study--diastolic-improvement-with-carvedilol--empagliflozin-in-patients-with-cirrhosis-100617716",false,"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.","ALL","18 Years","65 Years",{"count":72,"type":73},400,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79,80,81,82],"Cirrhotic Cardiomyopathy","Empagliflozin","Cardiometabolic Risk Factors","Cirrhosis",[84,85,86,87,88,89],"Empagliflozin in cirrhosis","Carvedilol in Cirrhosis","SGLT-2 inhibitor","Ascites","Diastolic heart failure","heart failure with preserved ejection fraction","2026-05-13",{"date":92,"type":93},"2026-05-14","ACTUAL",{"date":95,"type":93},"2026-04-01",{"date":97,"type":73},"2029-06-30",{"name":5,"class":6},1]