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

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called HRS-1893 to see how safe it is for people with a heart condition known as hypertrophic cardiomyopathy, which causes the heart muscle to thicken. The trial is currently not recruiting participants, but it aims to include adults aged 65 to 74 who have already participated in previous studies related to HRS-1893. To join the study, participants must be able to understand the study process and agree to it in writing. Women who can become pregnant will need to take a pregnancy test before starting the trial and must follow specific guidelines to prevent pregnancy during the study.

Participants in this trial can expect to receive close monitoring of their health while taking HRS-1893. However, certain individuals may not be eligible to join, such as those with a history of heart disease or specific heart rhythms, as well as those on certain medications in the past month. Overall, this study is important as it will help researchers understand the long-term safety of HRS-1893 for individuals with this heart condition.

Gender

ALL

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.