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

Shandong Suncadia Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Obstructive Hypertrophic Cardiomyopathy

Treatments: Drug: HRS-1893

Study type: Interventional

Funder types: Industry

Identifiers

NCT06516068

HRS-1893-201

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-85 years old, gender unlimited;
2. The diagnosis was obstructive hypertrophic cardiomyopathy.
3. Echocardiographic laboratory tests showed LVEF≥60%;
4. No previous left ventricular systolic dysfunction at any time (LVEF < 45%);
5. 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. Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF < 45%);
3. Previous history of aortic stenosis or subaortic fixed stenosis;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

HRS-1893

Experimental group

Treatment:

Drug: HRS-1893