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

A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy

This study tests the long-term safety of the oral drug HRS-1893 in people with hypertrophic cardiomyopathy who previously received HRS-1893.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07021963 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with hypertrophic cardiomyopathy who previously completed an HRS-1893 study, meet contraceptive and pregnancy-testing requirements, and have no recent myocardial infarction or significant coronary artery disease.

Not a fit: Patients with significant coronary artery disease, a history of myocardial infarction, recent use of disallowed negative inotropic medications, or who have not participated in prior HRS-1893 studies are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If HRS-1893 proves safe over the long term, it could support further development and offer a well-tolerated treatment option for people with hypertrophic cardiomyopathy.

How similar studies have performed: This is an extension of prior HRS-1893 trials to collect long-term safety data in HCM patients, though full results from earlier trials are not provided here.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Jianhong Lv

Conditions Hypertrophic Cardiomyopathy