[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-edema":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"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":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Cardiac Edema",[28,29],"fluid retention","heart failure","NOT_YET_RECRUITING","2025-04-22",{"date":33,"type":34},"2025-04-29","ACTUAL",{"date":36,"type":20},"2025-06-01",{"date":38,"type":20},"2027-05-31",{"name":40,"class":41},"Jemincare","INDUSTRY"]