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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 2

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: HRS-1893 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07021963

HRS-1893-205

Details and patient eligibility

About

This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Obstructive Hypertrophic Cardiomyopathy Group

Experimental group

Treatment:

Drug: HRS-1893 Tablet

Non-obstructive Hypertrophic Cardiomyopathy Group

Experimental group

Treatment:

Drug: HRS-1893 Tablet