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

RECRUITINGPHASE2

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

NCT07318103•Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 years on the day of signing the informed consent, regardless of gender;
•2. Hospitalised for acute heart failure within 24 hours prior to randomisation;
•3. Presence of heart failure symptoms before randomisation (exertional dyspnoea, nocturnal paroxysmal dyspnoea, orthopnoea, etc.) and at least one sign of fluid retention, including: pulmonary rales on auscultation, pitting oedema of the lower limbs, pulmonary congestion confirmed by chest imaging;
•4. NT-proBNP \>450 pg/mL within 12 hours prior to randomisation, \>600 pg/mL for patients with atrial fibrillation;
•5. 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

•1. Myocardial infarction, stroke or transient cerebral ischaemic attack, sustained ventricular tachycardia or ventricular fibrillation within 1 month prior to screening; or severe infection, major trauma or undergoing major or medium-sized surgery within 1 month prior to screening;
•2. Coronary revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), atrial flutter/fibrillation ablation, pacemaker implantation, valve repair/replacement, carotid or peripheral artery revascularisation, cardiac mechanical assist device therapy, heart transplantation within 1 month prior to screening or planned during the trial; or current severe coronary artery disease or cerebrovascular disease without revascularisation;
•3. Fluid retention symptoms and signs judged by the investigator to be caused by non-cardiac diseases; or concomitant conditions causing dyspnoea or fluid retention, such as acute exacerbation of chronic obstructive pulmonary disease, pulmonary heart disease, severe anaemia, decompensated liver cirrhosis, nephrotic syndrome, etc.;
•4. Acute heart failure requiring primary correction of the underlying cause as determined by the investigator, due to the following conditions: coronary atherosclerotic heart disease requiring revascularisation, active myocarditis, constrictive pericarditis, cardiac tamponade, complex congenital heart disease, untreated severe primary valvular heart disease, etc.;
•5. Previously diagnosed hypertrophic cardiomyopathy (obstructive or non-obstructive), amyloid cardiomyopathy;
•6. Use of cardiac mechanical assist device at the time of screening;
•7. Hypovolaemia or peripheral perfusion insufficiency at the time of screening, requiring vasoactive drugs, positive inotropic drugs or volume expansion therapy as assessed by the investigator;
•8. Anuria at the time of screening; or urinary difficulties caused by urinary tract obstruction, stones or tumours;
•9. Unable to perceive thirst at the time of screening, or any reason causing difficulty in fluid intake;
•10. Unable to complete weight measurement or urine collection;
+22 more criteria

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 31, 2025

Primary Completion Date

July 1, 2026

Completion Date

August 1, 2026

Last Updated

January 8, 2026

Enrollment

118

ESTIMATED participants

Conditions

Fluid Retention Caused by Heart Failure

Interventions

HRS-9057 injection set

DRUG

5% Glucose Injection

DRUG

Contacts

Na Li

CONTACT

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