Actively Recruiting
A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-09-10
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of HRS-1893 in people with hypertrophic cardiomyopathy, a condition affecting the heart muscle. This phase 2 clinical trial focuses on monitoring potential side effects and heart function changes over time. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. and aims to provide important information about how this medication affects heart health in this population. Participants receive the study drug HRS-1893 in tablet form. The trial includes two groups: one for obstructive hypertrophic cardiomyopathy and one for non-obstructive hypertrophic cardiomyopathy. This is an open-label, non-randomized study where all participants receive the medication. The treatment period and follow-up involve regular assessments to monitor safety and heart function. During the study, participants will undergo evaluations including tracking adverse events and monitoring heart function through left ventricular ejection fraction measurements over about one year. Additional tests include measuring cardiac biomarkers like troponin and NT-proBNP at 24 and 52 weeks. Participants will also be monitored for compliance and safety throughout the study, which lasts approximately one year, with the last data collection expected by December 2027.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must not be breastfeeding during the study.
- Female subjects of childbearing potential and male subjects with partners who are women of childbearing potential must agree to avoid donating sperm or eggs from signing consent until 3 months after the last dose and follow contraceptive requirements.
- Understand the study procedures, voluntarily agree to participate, and sign the informed consent form.
You will not qualify if you...
- History of coronary artery disease with more than 70% artery narrowing or previous heart attack.
- Use of negative inotropic medications other than disopyramide, beta-blockers, verapamil, or diltiazem within 4 weeks before screening.
- History of syncope or sustained ventricular tachycardia within 6 months before screening.
- Any other physical or psychological conditions that the investigator considers make participation unsafe or unsuitable, or that could affect compliance or completion of the study.
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.
Duration - About 1 year
Participants receive HRS-1893 tablets as part of the study treatment for hypertrophic cardiomyopathy.
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
J
Jianhong Lv
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here