Recruiting NCT07021963

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

Phase II Interventional Hypertrophic Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: HRS-1893 Tablet.
Who it may be relevant to: Registry conditions: Hypertrophic Cardiomyopathy. Basic parameters: 18 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Incidence and severity of adverse events (AEs). [Time frame: About 1 year.]
Incidence of left ventricular ejection fraction (LVEF) <50%. [Time frame: About 1 year.]

Secondary outcome measures (2)

The change in cardiac troponin from baseline. [Time frame: Week 24 and Week 52.]
The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline. [Time frame: Week 24 and Week 52.]

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 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.
Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.

Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction.
Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing

NCT: NCT07021963 · HRS-1893-205