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

Launched by JEMINCARE · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called JMKX003142 to see if it can help patients with cardiac edema, which is swelling caused by heart failure. The study aims to find out how safe and effective this treatment is compared to a placebo (a treatment that has no active ingredients). It will involve adults aged 18 and older who have been diagnosed with heart failure and are experiencing symptoms like swelling in the legs or difficulty breathing due to fluid buildup.

To participate, patients must be currently using certain diuretics (medications that help remove excess fluid) and still have fluid retention symptoms despite that treatment. Participants will be randomly assigned to receive either the new medication or a placebo, and they will be monitored closely throughout the trial. It's important to note that this trial is not yet recruiting participants, and there are some health conditions that would exclude individuals from joining, such as other heart diseases or recent serious heart events. Overall, this study aims to improve treatment options for those struggling with fluid retention due to heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Can fully understand the purpose and process of the study and voluntarily sign the informed consent form;
• • 2. Age ≥ 18 years old when signing the informed consent form;
• • 3. 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;
• 4. 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:
• • 1. 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;
• • 2. During the import phase, the weight of D-1 does not change by more than 1.0 kg compared to D-3.
• Exclusion Criteria:
• • 1. Edema caused by diseases other than heart failure；
• • 2. Subjects with ventricular assist devices during screening;
• • 3. Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;
• • 4. 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);
• • 5. Subjects with hypovolemia or suspected hypovolemia;
• • 6. Subject cannot feel thirst or have difficulty in fluid intake during screening;
• • 7. During screening, the systolic blood pressure is less than 90mmHg or the diastolic blood pressure is less than 60mmHg;
• • 8. Administered with tolvaptan 14days before randomization ；
• • 9. Pregnancy (female pregnancy test positive) or lactation period;