Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-03-05
84
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of a drug called HRS-1893 in adults with non-obstructive hypertrophic cardiomyopathy, a heart condition. This Phase II randomized, double-blind, placebo-controlled study aims to better understand how different doses of HRS-1893 affect the heart and plasma drug levels in this patient group. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will be randomly assigned to one of four groups: low-dose HRS-1893, low-dose placebo, high-dose HRS-1893, or high-dose placebo. The study includes up to 14 weeks of monitoring to assess safety and heart function, with key focus on left ventricular ejection fraction and adverse events. Different dosing regimens will be tested to evaluate the drug's impact. During the study, participants will undergo regular assessments including heart function tests and blood tests to measure markers such as cardiac troponin and peak oxygen uptake. Researchers will closely monitor adverse effects and heart performance over about 12 to 14 weeks. The total duration of participation includes screening, treatment, and follow-up to ensure thorough evaluation of HRS-1893's effects and safety profile.
CONDITIONS
Brief Title
A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years old, male or female
- Body mass index less than 35 kg/m2
- Understand and voluntarily agree to study procedures, signing informed consent
- Female participants of childbearing potential must have a negative pregnancy test before first dose and must not be breastfeeding
- Participants and partners of childbearing potential must agree to avoid donating sperm or eggs from consent until 3 months after last dose and follow contraceptive requirements
You will not qualify if you...
- Known or suspected heart muscle disease caused by infiltration, hereditary, or storage disorders
- Paroxysmal atrial flutter or atrial fibrillation with symptoms at screening
- History of fainting or sustained ventricular tachycardia within 6 months before screening
- Participation in any drug or medical device clinical trial within 3 months before screening
- Any other condition deemed unsuitable by the investigator for participation
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 - Up to 14 weeks
Participants receive either HRS-1893 or placebo tablets as part of the trial to evaluate safety and efficacy.
Weekly visits for up to 14 weeks
Trial Site Locations
Total: 1 location
1
Fuwai Hospital
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
J
Jianhong Lv
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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