RecruitingPhase 2NCT07318103

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

A Multicentre, Randomised, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Injectable HRS-9057 in Patients With Heart Failure-induced Fluid Retention


Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Enrollment

153 participants

Start Date

Dec 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HRS-9057 in people with heart failure who are retaining excess fluid (edema) and whose condition is not responding well to standard water pills (diuretics). **You may be eligible if...** - You are 18 or older - You have been hospitalized for acute heart failure within the past 24 hours - You have symptoms of heart failure (e.g., shortness of breath at rest, swollen legs, fluid in the lungs) and elevated BNP levels in your blood - Standard diuretic medication has not adequately reduced your fluid buildup **You may NOT be eligible if...** - You had a heart attack, stroke, or serious heart rhythm problem in the past month - You had major surgery or a serious infection in the past month - You recently had coronary stenting, bypass surgery, ablation for heart rhythm problems, or a pacemaker implanted - You have severe kidney failure or other major organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-9057 injection set

HRS-9057 injection set

DRUG5% Glucose Injection or 0.9% sodium chloride injection

5% Glucose Injection or 0.9% sodium chloride injection


Locations(1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT07318103