RecruitingPhase 3NCT07021976

A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy

A Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

216 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Obstructive Hypertrophic Cardiomyopathy

Summary

The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

Age 18-85 years old, gender unlimited.
BMI<35 kg/m2.
The diagnosis was obstructive hypertrophic cardiomyopathy.
Laboratory determination of echocardiography showed that Rest LVOT-G≥50 mmHg, or Rest LVOT-G≥30 mmHg and LVOT-G≥50 mmHg after Valsalva action.
Echocardiographic laboratory tests showed LVEF≥60%.
NYHA classification: Grade II - III.
Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.

Exclusion Criteria4

Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
Had a history of severe valvular heart disease.
Abnormal laboratory test results during screening, or any other clinically significant abnormal screening laboratory values, which are determined by the researcher to be unsuitable for inclusion.
Other circumstances where the researchers consider the subjects unsuitable to participate in this trial, such as physical or mental illnesses or conditions that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.

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