Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial on the Efficacy and Safety 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of the drug HRS-1893 in adults with heart failure with preserved ejection fraction, a condition where the heart's pumping ability is normal but symptoms of heart failure are present. This is a Phase II clinical trial sponsored by Shandong Suncadia Medicine Co., Ltd. The study aims to better understand how HRS-1893 affects patients with this type of heart failure. Participants will be randomly assigned to receive either HRS-1893 tablets or placebo tablets in a double-blind setup, meaning neither participants nor researchers know who receives the active drug. The study includes a 24-week treatment period where participants take the assigned tablets. Throughout the study, researchers will monitor drug levels in the blood and assess various heart function measures to evaluate the impact of the treatment. During the trial, participants will undergo evaluations including blood tests for heart-related proteins, questionnaires assessing heart failure symptoms, and physical tests like the six-minute walk test to measure exercise capacity. Heart function will be checked by echocardiography. Safety will be monitored by recording any adverse events up to 24 weeks. The total participation period covers treatment and follow-up assessments lasting up to around 29 weeks.
CONDITIONS
Brief 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 before screening, meeting diagnostic criteria including LVEF ≥ 60%, elevated NT-proBNP, and structural or functional heart abnormalities
- 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 over 90% without supplemental oxygen
- Female participants of childbearing potential must have a negative pregnancy test before first dose and not be breastfeeding, and agree to contraception requirements along with male partners
- Able to understand study procedures, voluntarily participate, and provide written informed consent
You will not qualify if you...
- Diagnosed or found to have hypertrophic cardiomyopathy or infiltrative/genetic/storage diseases causing HFpEF or myocardial hypertrophy
- Diagnosed or found to have hyperthyroidism
- History of left ventricular systolic dysfunction (LVEF < 45%)
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening
- History of cardiac arrest with resuscitation or ICD therapy for life-threatening ventricular arrhythmia within 6 months prior to screening
- Diagnosed or found to have atrial fibrillation
- Coronary artery disease with significant stenosis or recent myocardial infarction without completed revascularization
- Moderate to severe valve diseases such as aortic stenosis or mitral/tricuspid regurgitation
- Severe chronic obstructive pulmonary disease or other pulmonary diseases requiring home oxygen or recent hospitalization
- Acute respiratory infection at screening
- Recent acute decompensated heart failure requiring advanced therapies within 30 days prior to screening
- Significant malignancy history within past 5 years except certain cured or excised cancers
- Electrocardiogram abnormalities posing safety risks
- Clinically significant abnormal laboratory values unsuitable for enrollment
- Positive infectious disease screening including hepatitis, syphilis, or HIV
- Unable to complete six-minute walk test
- Unstable medication regimens for beta-blockers, calcium channel blockers or heart failure treatments
- Use of myosin inhibitor within 5 half-lives before study drug
- Participation in other drug or device clinical trials within 3 months prior to screening
- Other conditions deemed unsuitable by the investigator to ensure safety and protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either the HRS-1893 tablet or placebo to assess the efficacy and safety in treating heart failure with preserved ejection fraction.
Visits at baseline, Week 12, and Week 24
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
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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