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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-1893 Tablet

    Drug

    HRS-1893 tablet.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Obstructive Hypertrophic Cardiomyopathy GroupExperimental treatment 1 intervention
Group B: Non-obstructive Hypertrophic Cardiomyopathy GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs).

Time frame
About 1 year.
2

Incidence of left ventricular ejection fraction (LVEF) <50%.

Time frame
About 1 year.

Secondary outcomes

1

The change in cardiac troponin from baseline.

Time frame
Week 24 and Week 52.
2

The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.

Time frame
Week 24 and Week 52.

Other outcomes

Sponsors and contacts

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