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

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 3

Conditions: Obstructive Hypertrophic Cardiomyopathy

Treatments: Drug: HRS-1893 Tablets; Drug: HRS-1893 Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07021976

HRS-1893-301

Details and patient eligibility

About

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

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-85 years old, gender unlimited.
2. BMI<35 kg/m2.
3. The diagnosis was obstructive hypertrophic cardiomyopathy.
4. 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.
5. Echocardiographic laboratory tests showed LVEF≥60%.
6. NYHA classification: Grade II - III.
7. Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.

Exclusion criteria

1. Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
2. Had a history of severe valvular heart disease.
3. 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.
4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 2 patient groups, including a placebo group

HRS-1893 Group

Experimental group

Treatment:

Drug: HRS-1893 Tablets

HRS-1893 Placebo Group

Placebo Comparator group

Treatment:

Drug: HRS-1893 Placebo Tablets