A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema
ConditionCardiac Edema
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.
Eligibility criteria
Qualifiers
Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
Age ≥ 18 years old when signing the informed consent form;
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;
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;
Disqualifiers
Edema caused by diseases other than heart failure；
Subjects with ventricular assist devices during screening;
Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
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);
Trial design
Treatments tested in this trial
- JMKX003142 Injection
- JMKX003142 Injection
- JMKX003142 Injection
- JMKX003142 placebo
Treatment groups
160 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov