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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-9057 injection set

    Drug

    HRS-9057 injection set

  • 5% Glucose Injection or 0.9% sodium chloride injection

    Drug

    5% Glucose Injection or 0.9% sodium chloride injection

Treatment groups

153 Participants
are divided into 2 treatment groups
Group A: HRS-9057 for injectionExperimental treatment 1 intervention
Group B: 5% Glucose Injection or 0.9% sodium chloride injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute change in weight from baseline on day 8

Time frame
within 8 days after the start of administration

Secondary outcomes

1

Absolute change in body weight from baseline at each visit during treatment

Time frame
At each visit during treatment,within 8 days after the start of administration
2

The proportion of participants requiring remedial treatment during therapy as defined by the protocol

Time frame
after the last case has left the group,within 1years after the first case in
3

Total dose of loop diuretics during treatment

Time frame
within 8 days after the start of administration
4

The incidence and severity of any adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) occurring after any treatment

Time frame
within 8 days after the start of administration

Other outcomes

Sponsors and contacts

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