RecruitingPhase 2

A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction

China48 participantsStarted 2026-03-30

Plain-language summary

This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. Age ≥ 40 years at screening, regardless of gender;
✓. Body mass index \< 35 kg/m²;
✓. Diagnosed with chronic heart failure before screening, and meeting relevant diagnostic criteria during the screening period: (1) Transthoracic echocardiography (TTE) at screening showing a resting left ventricular ejection fraction (LVEF) ≥ 60%; (2) Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) during the screening period; (3) Echocardiography showing structural or functional abnormalities of the heart, etc.;
✓. New York Heart Association (NYHA) classification of II or III at screening;
✓. KCCQ-CSS score between ≥25 and ≤75 at screening;
✓. Resting oxygen saturation \>90% without supplemental oxygen at screening;
✓. Female participants of childbearing potential must have a negative serum pregnancy test before the first dose and must not be breastfeeding during the study. Female participants of childbearing potential and male participants whose partners are women of childbearing potential must agree to avoid donating sperm/eggs from the time of signing the informed consent until three months after the last dose of the study drug and comply with relevant contraceptive requirements;
✓. Understand the study procedures and methods, voluntarily participate in this trial, and provide written informed consent.

Exclusion criteria

✕. Previously diagnosed or found during screening with hypertrophic cardiomyopathy (HCM), or having infiltrative/genetic/storage diseases that cause heart failure with preserved ejection fraction (HFpEF)/myocardial hypertrophy (such as amyloidosis, Fabry disease, Noonan syndrome with left ventricular hypertrophy), or complete M protein or monoclonal light chain (such as κ or λ) detected in serum protein electrophoresis and serum immunofixation electrophoresis during screening (researchers may deem not applicable if amyloidosis/multiple myeloma are excluded);
✕. Previously diagnosed or found during screening with hyperthyroidism;
✕. At any time in their clinical history, previously experienced left ventricular systolic dysfunction (LVEF \<45%);
✕. History of syncope or sustained ventricular tachycardia within 6 months prior to screening;
✕. Previously experienced cardiac arrest with resuscitation at any time or received ICD therapy for life-threatening ventricular arrhythmia within 6 months prior to screening;
✕. Previously diagnosed or found during screening with atrial fibrillation;
✕. Coronary artery disease (stenosis \>70% in one or more coronary arteries) or myocardial infarction: newly developed within 6 months prior to screening, or occurred more than 6 months prior without completed revascularization (such as percutaneous coronary intervention or coronary artery bypass grafting);
✕. Moderate to severe aortic stenosis, hemodynamically significant mitral stenosis, or severe mitral/tricuspid regurgitation at screening (as determined by the investigator);

What they're measuring

Incidence and severity of adverse events (AEs).

Timeframe: Week 24.

Trial details

NCT IDNCT07269717

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Jianhong Lv

+86-0518-82342973 jianhong.lv.jl9@hengrui.com

View on ClinicalTrials.gov More Heart Failure With Preserved Ejection Fraction trials