> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-to-evaluate-the-long-term-safety-of-hrs-9f6191c7-54bf-40c6-9199-501244b86f1e > Record changed: 2026-10-13 # A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy NCT07021963 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) Lead sponsor Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) Start date 2025-07-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Title and summary **Summary** This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Short title** A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Official title** A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **First posted** 2025-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Registry last updated** 2025-09-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Start date** 2025-07-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Lead sponsor** Shandong Suncadia Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Identifiers **Registry ID** NCT07021963 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **ClinicalTrials.gov ID** NCT07021963 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Outcomes ### Primary outcomes 1. Incidence and severity of adverse events (AEs). Timeframe: About 1 year. 2. Incidence of left ventricular ejection fraction (LVEF) <50%. Timeframe: About 1 year. ### Secondary outcomes 1. The change in cardiac troponin from baseline. Timeframe: Week 24 and Week 52. 2. The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline. Timeframe: Week 24 and Week 52. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** No ### Inclusion criteria 1. Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies. 2. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements. 3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing. ### Exclusion criteria 1. Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction. 2. Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening. 3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening. 4. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Sites - Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07021963) ## Related records ### Drugs (1) - [LB-102](https://trialight.com/data/asset/lb-102-4fafa13e-2b6e-4289-b389-c2f1e2b594e9.md) ### Lead sponsors (1) - [Shandong Suncadia Medicine Co., Ltd.](https://trialight.com/data/company/shandong-suncadia-medicine-co-ltd-c4ebee86-20f2-45b5-9857-30794a216c9a.md) ### Conditions (1) - [Hypertrophic cardiomyopathy](https://trialight.com/data/condition/hypertrophic-cardiomyopathy-2bcaf1dc-551c-50d7-8f5b-4b8457815d3c.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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