[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589023":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":23,"interventions":40,"overallOfficials":11,"centralContacts":54,"locations":11,"responsibleParty":60,"collaborators":11,"id":62,"slug":11,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":11},{"fullName":5,"class":6},"Jemincare","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"body weight",null,"5 days",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":19},"TRIPLE",[20,21,22],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[24,29,32,35],{"label":25,"type":26,"description":11,"interventionNames":27},"low dose group","EXPERIMENTAL",[28],"Drug: JMKX003142 Injection",{"label":30,"type":26,"description":11,"interventionNames":31},"median dose group",[28],{"label":33,"type":26,"description":11,"interventionNames":34},"high dose group",[28],{"label":36,"type":37,"description":11,"interventionNames":38},"placebo group","PLACEBO_COMPARATOR",[39],"Drug: JMKX003142 placebo",[41,46,48,50],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"DRUG","JMKX003142 Injection","JMKX003142 injection for experimental groups once daily for five days.",[33],{"type":42,"name":43,"description":44,"armGroupLabels":47,"otherNames":11},[25],{"type":42,"name":43,"description":44,"armGroupLabels":49,"otherNames":11},[30],{"type":42,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"JMKX003142 placebo","JMKX003142 placebo for placebo groups once daily for five days.",[36],[55],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Yang Zhang","CONTACT","+8618768467776","zhangyang@jemincare.com",{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":71,"type":72},160,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78],"Cardiac Edema",[80,81],"fluid retention","heart failure","NOT_YET_RECRUITING","2025-04-22",{"date":85,"type":86},"2025-04-29","ACTUAL",{"date":88,"type":72},"2025-06-01",{"date":90,"type":72},"2027-05-31",{"name":5,"class":6}]