Status:
NOT_YET_RECRUITING
A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema
Lead Sponsor:
Jemincare
Conditions:
Cardiac Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Pa...
Eligibility Criteria
Inclusion
- 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:
- 1\) At least 40mg/day 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.
- 5\. After the background treatment in the run-in period, the subject still has the following two conditions:
- 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
- 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 ；
- Pregnancy (female pregnancy test positive) or lactation period;
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06949020
Start Date
June 1 2025
End Date
May 31 2027
Last Update
April 29 2025
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