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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06516068

Enrollment

Registered

2024-07-23

Start date

2024-08-11

Completion date

2025-08-31

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Hypertrophic Cardiomyopathy

Brief summary

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

Interventions

DRUGHRS-1893

HRS-1893

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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;

Design outcomes

Primary

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	After 12 weeks of HRS-1893 treatment

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026