Not Yet RecruitingPhase 2

A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema

160 participantsStarted 2025-06-01

Plain-language summary

To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;
✓. The screening phase is currently undergoing or preparing to use one of the following diuretic therapy as background treatment during the run-in period:
✓. 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;
✓. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.

Exclusion criteria

✕. 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);
✕. Subjects with hypovolemia or suspected hypovolemia;
✕. Subject cannot feel thirst or have difficulty in fluid intake during screening;
✕. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
✕. Administered with tolvaptan 14days before randomization ；

What they're measuring

body weight

Timeframe: 5 days

Trial details

NCT IDNCT06949020

SponsorJemincare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

Yang Zhang

+8618768467776 zhangyang@jemincare.com

View on ClinicalTrials.gov More Cardiac Edema trials