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

Phase 3

Recruiting

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893 Tablets; Drug: HRS-1893 Placebo Tablets

• Registration Number: NCT07021976
• 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: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Study First Posted: 2025-06-15
• Status Verified: 2025-08
• Study Start: 2025-08-11
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-20
• Primary Completion: 2026-09
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-1893 Group	HRS-1893 Tablets	-
HRS-1893 Placebo Group	HRS-1893 Placebo Tablets	-

Primary Outcome Measures

Name	Time	Method
The clinical response rate of treatment with HRS-1893.	After 24 weeks of HRS-1893 treatment.

Secondary Outcome Measures

Name	Time	Method
The incidence of major adverse cardiac events (cardiovascular death, cardiac arrest, non-fatal stroke, non-fatal myocardial infarction, hospitalization for cardiovascular events).	About 29 weeks.
Incidence and severity of any adverse events.	About 29 weeks.
The change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) from the baseline.	Week 12 and Week 24.

Trial Locations

Locations (2)

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, Beijing, China

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; 🇨🇳 Beijing, Beijing, China