RecruitingPhase 2

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

China153 participantsStarted 2025-12-31

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Judged to have poor response to loop diuretics before randomisation: presence of symptoms and signs of fluid retention after the administration of a cumulative dose of oral or intravenous loop diuretics equivalent to oral furosemide ≥40 mg (or equivalent doses of other loop diuretics#) within the past 12 hours.

Exclusion criteria

✕. 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;
✕. Fluid retention symptoms and signs determined by the investigator to be caused by non-cardiac diseases; or concomitant with other diseases that cause dyspnea or fluid retention, such as acute exacerbation of chronic obstructive pulmonary disease, severe anemia, decompensated liver cirrhosis, nephrotic syndrome, etc.
✕. 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;
✕. Previously diagnosed with hypertrophic cardiomyopathy and currently still in the hypertrophic phase (obstructive or non-obstructive), or amyloid cardiomyopathy;
✕. Use of cardiac mechanical assist device at the time of screening;
✕. Presence of hypovolemia or peripheral hypoperfusion at screening, assessed by the investigator as requiring treatment with vasoconstrictors, positive inotropic agents, or volume resuscitation.
✕. Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours;

What they're measuring

Absolute change in weight from baseline on day 8

Timeframe: within 8 days after the start of administration

Trial details

NCT IDNCT07318103

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Na Li

+0518-82342973 na.li.nl80@hengrui.com

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