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

Phase 2

Active, not recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893

• Registration Number: NCT06516068
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Study Start: 2024-08-11
• Primary Completion: 2024-11-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-1893	HRS-1893	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in NT-proBNP	Baseline to Week 12
Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)	Through study completion, an average of 68 weeks
Change in LVEF	Baseline to Week 12
Change in LVOT-VTI	Baseline to Week 12
Change in LV-GLS	Baseline to Week 12
Change in cardiac troponin	Baseline to Week 12
plasma concentration of HRS-1893	Through study completion, an average of 68 weeks
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
Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)	Baseline to Week 12
Change in LV-FS	Baseline to Week 12
Change in Rest LVOT-G	Baseline to Week 12
Change in Valsalva LVOT-G	Baseline to Week 12

Trial Locations

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences (CAMS); 🇨🇳 Beijing, Beijing, China