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

July 15, 2025 updated by: Shandong Suncadia Medicine Co., Ltd.

A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRS-1893
Drug: HRS-1893
HRS-1893

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver
Time Frame: After 12 weeks of HRS-1893 treatment
After 12 weeks of HRS-1893 treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in LVEF
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in LVOT-VTI
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in LV-FS
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in LV-GLS
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in Rest LVOT-G
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in Valsalva LVOT-G
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in cardiac troponin
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in NT-proBNP
Time Frame: Baseline to Week 12
Baseline to Week 12
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Time Frame: Baseline to Week 12
Baseline to Week 12
Proportion of participants with ≥ 1 class improvement in NYHA Functional Class
Time Frame: Baseline to Week 12
Baseline to Week 12
Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)
Time Frame: Through study completion, an average of 68 weeks
Through study completion, an average of 68 weeks
plasma concentration of HRS-1893
Time Frame: Through study completion, an average of 68 weeks
Through study completion, an average of 68 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2024

Primary Completion (Actual)

November 18, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-1893-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Hypertrophic Cardiomyopathy

Clinical Trials on HRS-1893

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe