A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
A Multicentre, Randomized, Double-blind, Placebo-parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of HRS-1893 Tablets in the Treatment of Obstructive Hypertrophic Cardiomyopathy
1 other identifier
interventional
216
1 country
1
Brief Summary
The study is being conducted to evaluate the efficacy and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2025
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2025
CompletedFirst Posted
Study publicly available on registry
June 15, 2025
CompletedStudy Start
First participant enrolled
August 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
August 20, 2025
August 1, 2025
1.1 years
June 6, 2025
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The clinical response rate of treatment with HRS-1893.
After 24 weeks of HRS-1893 treatment.
Secondary Outcomes (3)
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.
Study Arms (2)
HRS-1893 Group
EXPERIMENTALHRS-1893 Placebo Group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18-85 years old, gender unlimited.
- BMI\<35 kg/m2.
- The diagnosis was obstructive hypertrophic cardiomyopathy.
- 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.
- Echocardiographic laboratory tests showed LVEF≥60%.
- NYHA classification: Grade II - III.
- Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
You may not qualify if:
- Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM).
- Had a history of severe valvular heart disease.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2025
First Posted
June 15, 2025
Study Start
August 11, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
August 20, 2025
Record last verified: 2025-08