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NCT Number: NCT07021963

A 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Lianming Kang

CONTACT

[email protected]

+86-010-88396870

Lianming Kang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HRS-1893 Tablet

Drug

HRS-1893 tablet.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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