Actively Recruiting
A Multicentre, Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in Obstructive Hypertrophic Cardiomyopathy
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-08-20
216
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of HRS-1893 tablets in treating patients with obstructive hypertrophic cardiomyopathy, a condition that affects the heart muscle. This Phase III study is sponsored by Shandong Suncadia Medicine Co., Ltd. and aims to assess how well HRS-1893 works compared to a placebo. The study focuses on patients aged 18 to 85 years who meet specific diagnostic and heart function criteria. Participants will be randomly assigned to receive either HRS-1893 tablets or placebo tablets in a double-blind manner, meaning neither the participants nor the researchers know which treatment is given. The treatment period lasts 24 weeks, during which the clinical response rate to HRS-1893 will be evaluated. Secondary outcomes include tracking major heart-related events, adverse effects, and changes in quality of life measured by the Kansas City Cardiomyopathy Questionnaire at weeks 12 and 24. Throughout the study, participants will undergo echocardiographic assessments to monitor heart function and other laboratory tests to ensure safety. They will be closely monitored for any adverse events over approximately 29 weeks. Participants are expected to follow the study protocol strictly and provide informed consent before joining. The total participation time includes treatment and follow-up to evaluate safety and outcomes comprehensively.
CONDITIONS
Brief Title
A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years, any gender
- Body mass index (BMI) less than 35 kg/m2
- Diagnosed with obstructive hypertrophic cardiomyopathy
- Echocardiography shows Rest LVOT gradient 50 mmHg, or Rest LVOT gradient 30 mmHg and LVOT gradient 50 mmHg after Valsalva maneuver
- Left ventricular ejection fraction (LVEF) of 60% or higher
- New York Heart Association (NYHA) classification grade II to III
- Understand the study and provide informed consent, willing to follow study protocol fully
You will not qualify if you...
- Known or suspected invasive, genetic, or storage diseases causing cardiac hypertrophy similar to obstructive hypertrophic cardiomyopathy (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- History of severe valvular heart disease
- Abnormal lab test results at screening deemed unsuitable by researchers
- Other conditions judged by researchers to increase risk, reduce compliance, or affect trial completion
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 HRS-1893 tablets or placebo tablets as part of the trial treatment.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
Y
Yun Jin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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