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NCT06949020 | NOT YET RECRUITING | Cardiac Edema

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

Jmincare

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 Patients.

Condition or disease

Cardiac Edema

Intervention/treatment

JMKX003142 Injection

JMKX003142 Injection

JMKX003142 Injection

JMKX003142 placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Efficacy and Safety of JMKX003142 Injection in Heart Failure Patients With Volume Overload：A Phase II, Randomized, Double-blind, Placebo-controlled Study
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2027-01-31
Estimated Study Completion Date : 2027-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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;
A Dose-finding Study of JMKX003142 in Treatment of Cardiac Edema

Location Details

NCT06949020

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