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

NCT ID: NCT07021976

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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Conditions

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Obstructive Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HRS-1893 Group

Group Type EXPERIMENTAL

HRS-1893 Tablets

Intervention Type DRUG

HRS-1893 tablets.

HRS-1893 Placebo Group

Group Type PLACEBO_COMPARATOR

HRS-1893 Placebo Tablets

Intervention Type DRUG

HRS-1893 placebo tablets.

Interventions

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HRS-1893 Tablets

HRS-1893 tablets.

Intervention Type DRUG

HRS-1893 Placebo Tablets

HRS-1893 placebo tablets.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Jin

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Lianming Kang

Role: primary

+86-010-88396870

Other Identifiers

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HRS-1893-301

Identifier Type: -

Identifier Source: org_study_id

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