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

NCT07021963 | Recruiting Phase 2

• 1 other identifier: HRS-1893-205
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs).

  About 1 year.

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

  About 1 year.

Secondary Outcomes (2)

• The change in cardiac troponin from baseline.

  Week 24 and Week 52.

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

  Week 24 and Week 52.

Study Arms (2)

Obstructive Hypertrophic Cardiomyopathy Group

EXPERIMENTAL

Drug: HRS-1893 Tablet

Non-obstructive Hypertrophic Cardiomyopathy Group

EXPERIMENTAL

Drug: HRS-1893 Tablet

Interventions

HRS-1893 Tablet DRUG

HRS-1893 tablet.

Non-obstructive Hypertrophic Cardiomyopathy Group; Obstructive Hypertrophic Cardiomyopathy Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Jianhong Lv

CONTACT

+86-0518-82342973; jianhong.lv.jl9@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (1)