Actively Recruiting
A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-05-11
48
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.
CONDITIONS
Official Title
A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older at screening, any gender
- Body mass index less than 35 kg/m²
- Diagnosed with chronic heart failure with preserved ejection fraction confirmed by echocardiography and elevated NT-proBNP levels
- New York Heart Association (NYHA) class II or III at screening
- Kansas City Cardiomyopathy Questionnaire Clinical Summary Score between 25 and 75 at screening
- Resting oxygen saturation greater than 90% without supplemental oxygen
- Female participants of childbearing potential must have a negative pregnancy test before first dose and not be breastfeeding during the study
- Participants of childbearing potential and their partners must agree to use contraception from consent until three months after last dose
- Ability to understand study procedures and provide written informed consent
You will not qualify if you...
- Diagnosis or evidence of hypertrophic cardiomyopathy or infiltrative/genetic/storage diseases causing heart failure or myocardial hypertrophy
- Diagnosis or evidence of hyperthyroidism
- History of left ventricular systolic dysfunction with ejection fraction less than 45%
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening
- History of cardiac arrest with resuscitation or ICD therapy within 6 months prior to screening
- Diagnosis or evidence of atrial fibrillation
- Significant coronary artery disease or recent myocardial infarction without completed revascularization
- Moderate to severe aortic stenosis, significant mitral stenosis, or severe mitral/tricuspid regurgitation
- Severe chronic obstructive pulmonary disease or other pulmonary diseases requiring advanced therapies or recent hospitalization
- Acute respiratory infection at screening
- Recent use of intravenous heart failure treatments within 30 days prior to screening
- History of significant malignancy in past 5 years except certain cured or excised cancers
- Electrocardiogram abnormalities posing safety risks
- Clinically significant abnormal lab results unsuitable for enrollment
- Positive infectious disease screening (hepatitis B, C, syphilis, HIV)
- Inability to complete six-minute walk test due to physical limitations
- Unstable use of beta-blockers, diltiazem, or verapamil prior to screening
- Unstable use of heart failure medications prior to screening
- Use of myosin inhibitors within 5 half-lives prior to trial drug administration
- Participation in any drug or device clinical trial within 3 months prior to screening
- Other conditions deemed unsuitable by investigator including physiological or psychological issues impacting compliance or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jianhong Lv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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