Long-term safety of HRS-1893 for people with hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional follow-up enrolls adults with hypertrophic cardiomyopathy who have completed earlier HRS-1893 studies to monitor safety over an extended period. Participants will continue taking HRS-1893 tablets and attend regular clinic visits for cardiac exams, laboratory tests, and monitoring for adverse events. Key exclusion criteria include significant coronary artery disease, prior myocardial infarction, and recent use of disallowed negative inotropic medications. The trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and conducted at Fuwai Hospital in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
2. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.

Exclusion Criteria:

1. Previous history of coronary artery disease (stenosis of one or more coronary arteries \>70%) or myocardial infarction.
2. Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jianhong Lv
• Email: jianhong.lv.jl9@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.