Actively Recruiting
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-04-09
153
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention
CONDITIONS
Official Title
Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of informed consent
- Hospitalized for heart failure within 72 hours before randomization
- Presence of heart failure symptoms and at least one clinical sign of fluid retention before randomization
- NT-proBNP > 450 pg/mL within 12 hours before randomization, or > 600 pg/mL if patient has atrial fibrillation; or BNP > 150 pg/mL, or > 200 pg/mL if patient has atrial fibrillation
- Poor response to loop diuretics before randomization, with symptoms/signs of fluid retention after receiving at least 40 mg oral furosemide (or equivalent) within the past 12 hours
You will not qualify if you...
- Myocardial infarction, stroke, transient ischemic attack, sustained ventricular tachycardia, ventricular fibrillation, severe trauma, or major/moderate surgery within 1 month prior to screening
- Coronary revascularization, valve surgery, carotid or peripheral arterial procedures, mechanical circulatory support, or heart transplant within 1 month prior or planned during study; severe coronary or cerebrovascular disease without revascularization
- Fluid retention caused by non-cardiac diseases or other conditions causing dyspnea or fluid retention
- Acute heart failure requiring correction of underlying causes such as coronary artery disease needing revascularization, myocarditis, pericarditis, tamponade, complex congenital heart disease, or severe untreated valvular disease
- Diagnosed hypertrophic or amyloid cardiomyopathy
- Use of cardiac mechanical assist device at screening
- Hypovolemia or peripheral hypoperfusion requiring vasoconstrictors, inotropes, or volume resuscitation
- Anuria or urinary difficulties due to obstruction, stones, or tumors
- Inability to perceive thirst or difficulties with fluid intake
- Inability to complete weight or urine measurements
- Impaired consciousness or hepatic encephalopathy currently or history of
- Recent organ system malignancy requiring ongoing treatment
- History of drug or substance abuse within 1 year
- Body mass index less than 18.5 or greater than 35 kg/m2
- Symptomatic hypotension or systolic blood pressure below 90 mmHg
- Severe kidney dysfunction (eGFR < 15 mL/min/1.73 m2) or on/planned for dialysis
- Elevated liver enzymes more than three times upper limit, unless due to heart failure
- Abnormal serum sodium or potassium levels
- Known or suspected allergy to study drugs or components
- Participation in another drug or device trial within 3 months
- Recent use of tolvaptan, OPC-61815, thiazide diuretics, or drugs affecting tolvaptan metabolism
- Current need for blood transfusion therapy
- Mental incapacity or communication disorders affecting study participation
- Pregnant or breastfeeding, or unwillingness to use contraception as required
- Any condition judged by investigator to affect safety or study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
N
Na Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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