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

Prior treatment

• 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);

Other illness

• Edema caused by diseases other than heart failure；
• Subjects diagnosed with active myocarditis, myocardial amyloidosis, hypertrophic cardiomyopathy (excluding dilated phase), or valve disease with obvious valve stenosis during screening;

Other

• Subjects with ventricular assist devices during screening;
• 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;

• 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.