Cardiac Edema
Conditions
Keywords
fluid retention, heart failure
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.
Interventions
JMKX003142 injection for experimental groups once daily for five days.
DRUGJMKX003142 placebo
JMKX003142 placebo for placebo groups once daily for five days.
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight | 5 days |
Countries
China
Outcome results
None listed