[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"HCQ group","EXPERIMENTAL","Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months",[13,14],"Drug: Hydroxychloroquine","Drug: Prednisolone",{"label":16,"type":17,"description":18,"interventionNames":19},"Non-HCQ group","ACTIVE_COMPARATOR","Prednisolone 20mg qd for 12 months",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Hydroxychloroquine","Hydroxychloroquine 200mg qd",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Prednisolone","Prednisolone 20mg qd",[9,16],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Dao Wen Wang, MD, PhD","CONTACT","+86-027-6937-8422","dwwang@tjh.tjmu.edu.cn",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Wu He","+8613972334305","hewu0912@163.com",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":50,"coordinates":51},"Point",[52,53],114.26667,30.58333,{"lat":53,"lon":52},[56,58],{"name":33,"role":34,"phone":57,"phoneExt":26,"email":36},"86-27-6937-8422",{"name":59,"role":34,"phone":39,"phoneExt":26,"email":40},"Wu He, MD",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dao Wen Wang","Prof.",[65,67],{"name":66,"class":6},"Wuhan Central Hospital",{"name":68,"class":6},"Taihe Hospital","100513110","phase-2-the-effects-of-hydroxychloroquine-in-patients-with-inflammatory-cardiomyopathy-100513110",false,"NCT05961202","The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy","The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis","HYPIC","Inclusion criteria:\n\n1. Male or female patient aged from 18 to 80 years;\n2. Left ventricular dysfunction \\[left ventricular ejection fraction (LVEF) \\\u003C50%\\] diagnosed by echocardiography (Simpson's biplane) within 30 days before randomization;\n3. Chronic heart failure (lasting \\>6 months) unresponsive to conventional supportive therapy;\n4. High-sensitivity cardiac Troponin I (hs-cTnI) \\>26.2 pg\u002FmL and N-terminal-pro-B-type natriuretic peptide (NT-proBNP) \\>169pg\u002FmL;\n5. Suffered from confirmed fulminant myocarditis in the past;\n6. Diagnosed with chronic inflammatory cardiomyopathy confirmed by myocardial biopsy1;\n7. Absence of cardiotropic viruses at polymerase chain reaction analysis;\n8. Volunteer for the study and written informed consent;\n\nExclusion criteria:\n\n1. Age \\\u003C18 or \\>80 years;\n2. Acute myocardial infarction occurred within the past month;\n3. Subjects who have undergone cardiac surgery or cerebrovascular accidents within 6 months;\n4. Preparing for heart transplantation;\n5. With malignant arrhythmias such as long QT syndrome;\n6. Pregnancy or lactation;\n7. Have participated in any drug clinical trial within the three months;\n8. Presence of contraindications to prednisolone and\u002For hydroxychloroquine (including hypersensitivity to prednisone or hydroxychloroquine, mainly untreated systemic infection, uncontrolled diabetes, poorly controlled endocrine diseases, osteoporosis, gastric or duodenal ulcer, uncontrolled hypertension, leukocytopenia (leukocyte counts \\\u003C 4×109\u002FL), neutropenia (neutrophils \\\u003C 1.5×109\u002FL), thrombocytopenia (platelet levels \\\u003C 130×109\u002FL), anemia (hemoglobin levels \\\u003C 11 g\u002FdL).\n9. Confirmed or possible systemic inflammatory diseases;\n10. On the brink of death or life expectancy of less than 1 year;\n11. Drug or alcohol abuse;\n12. cannot persist in taking medication due to various reasons;\n13. Inability to provide informed consent.","ALL","18 Years","80 Years",{"count":81,"type":82},200,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE2","PHASE3","Evaluating the long-term therapeutic effects and safety of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study",[89,90],"Inflammatory Cardiomyopathy","Myocarditis",[92,90,23,93],"Inflammatory cardiomyopathy","Randomized controlled trial","2024-10-06",{"date":96,"type":97},"2024-10-09","ACTUAL",{"date":99,"type":97},"2021-11-01",{"date":101,"type":82},"2025-11-01",{"name":5,"class":6},1]