Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

Phase II clinical study of HRS-9057 injection in patients with heart failure-induced fluid retention

Eligibility criteria

Qualifiers

Aged ≥18 years on the day of signing the informed consent, regardless of gender;

Hospitalization due to heart failure within 72 hours prior to randomization.;

At screening and prior to randomization, presence of heart failure symptoms (exertional dyspnea, paroxysmal nocturnal dyspnea, orthopnea, etc.) and at least one sign of fluid retention, including: auscultatory rales in the lungs, pitting edema of the lower extremities, pulmonary congestion confirmed by chest imaging;;

NT-proBNP > 450 pg/mL within 12 hours prior to randomization, or > 600 pg/mL in patients with atrial fibrillation; or BNP > 150 pg/mL, or > 200 pg/mL in patients with atrial fibrillation.

Disqualifiers

Occurrence of myocardial infarction, stroke or transient ischemic attack, sustained ventricular tachycardia or ventricular fibrillation within 1 month prior to screening; or severe trauma or major/moderate surgery within 1 month prior to screening;

Coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), valve repair/replacement, carotid or peripheral arterial revascularization, mechanical circulatory support device therapy, heart transplantation within 1 month prior to screening or planned during the study; or presence of severe coronary artery disease or cerebrovascular disease without revascularization that may lead to acute events during hospitalization;

The signs and symptoms of fluid retention are judged by the investigator as mainly attributable to non-cardiac causes, including acute exacerbation of chronic obstructive pulmonary disease, severe anemia, decompensated cirrhosis, nephrotic syndrome, and so on.

The investigator determines that this hospitalization is due to acute heart failure requiring initial correction of the underlying cause, including: coronary atherosclerotic heart disease requiring revascularization, active myocarditis, constrictive pericarditis, cardiac tamponade, complex congenital heart disease, or symptomatic severe untreated primary valvular heart disease that may lead to acute events during hospitalization;

Trial design

Treatments tested in this trial

  • HRS-9057 injection set
  • 5% Glucose Injection or 0.9% sodium chloride injection

Treatment groups

153 Participants
are divided into 2 treatment groups