[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589023":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":39,"locations":11,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":11,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":11},{"fullName":5,"class":6},"Jemincare","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"low dose group","EXPERIMENTAL",null,[13],"Drug: JMKX003142 Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"median dose group",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"high dose group",[13],{"label":21,"type":22,"description":11,"interventionNames":23},"placebo group","PLACEBO_COMPARATOR",[24],"Drug: JMKX003142 placebo",[26,31,33,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","JMKX003142 Injection","JMKX003142 injection for experimental groups once daily for five days.",[18],{"type":27,"name":28,"description":29,"armGroupLabels":32,"otherNames":11},[9],{"type":27,"name":28,"description":29,"armGroupLabels":34,"otherNames":11},[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"JMKX003142 placebo","JMKX003142 placebo for placebo groups once daily for five days.",[21],[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Yang Zhang","CONTACT","+8618768467776","zhangyang@jemincare.com",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100589023","phase-2-a-dose-finding-study-of-jmkx003142-in-treatment-of-cardiac-edema-100589023",false,"NCT06949020","A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema","Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study","Inclusion Criteria:\n\n1. Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;\n2. Age ≥ 18 years old when signing the informed consent form;\n3. At the screening stage, it has been definitely diagnosed as heart failure, and it is combined with one of the following clinical manifestations related to body fluid retention: edema of both lower limbs, jugular vein engorgement, pulmonary congestion;\n4. The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:\n\n1\\) At least 40mg\u002Fday of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.\n\n5\\. After the background treatment in the run-in period, the subject still has the following two conditions:\n\n1. One of the following clinical manifestations related to fluid retention still exists after the induction phase treatment: edema of both lower limbs, jugular vein dilatation, pulmonary congestion;\n2. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.\n\nExclusion Criteria:\n\n1. Edema caused by diseases other than heart failure；\n2. Subjects with ventricular assist devices during screening;\n3. Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;\n4. Acute myocardial infarction occurred within 30 days prior to screening; subjects with a history of persistent ventricular tachycardia or ventricular fibrillation within the 30 days prior to screening (those without implantable defibrillators); History of cerebrovascular disease within 6 months prior to screening (excluding asymptomatic cerebral infarction);\n5. Subjects with hypovolemia or suspected hypovolemia;\n6. Subject cannot feel thirst or have difficulty in fluid intake during screening;\n7. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;\n8. Administered with tolvaptan 14days before randomization ；\n9. Pregnancy (female pregnancy test positive) or lactation period;","ALL","18 Years",{"count":57,"type":58},160,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","To Evaluate the Safety, Efficacy, and Pharmacokinetic\u002FPharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.",[64],"Cardiac Edema",[66,67],"fluid retention","heart failure","NOT_YET_RECRUITING","2025-04-22",{"date":71,"type":72},"2025-04-29","ACTUAL",{"date":74,"type":58},"2025-06-01",{"date":76,"type":58},"2027-05-31",{"name":5,"class":6}]