Hypertrophic CardiomyopathyPhase 2NCT07021963
A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
A Phase 2 study testing HRS-1893 Tablet in people with Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
- 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.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
Who cannot join
- Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction.
- Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100037
Lianming Kang, +86-010-88396870, lianmingkang@126.com
Lianming Kang
About this study
Official title: A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- HRS-1893 Tablet
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893 TabletDrug
HRS-1893 tablet.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Hypertrophic Cardiomyopathy Group | Experimental | Not described Receives: Drug: HRS-1893 Tablet |
| Non-obstructive Hypertrophic Cardiomyopathy Group | Experimental | Not described Receives: Drug: HRS-1893 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs).
Measured: About 1 year.
Incidence of left ventricular ejection fraction (LVEF) <50%.
Measured: About 1 year.
Secondary outcomes (2)
The change in cardiac troponin from baseline.
Measured: Week 24 and Week 52.
The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.
Measured: Week 24 and Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start4 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021963
- Sponsor's protocol ID
- HRS-1893-205
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07021963
- Acronym / sponsor ID
- HRS-1893-205
- Conditions
- Hypertrophic Cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Hypertrophic Cardiomyopathy Group | Experimental | Drug: HRS-1893 Tablet |
| Non-obstructive Hypertrophic Cardiomyopathy Group | Experimental | Drug: HRS-1893 Tablet |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
- 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.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
Key exclusion criteria (4 listed)
- Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction.
- Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-1893 TabletHRS-1893 tablet. | Drug | Non-obstructive Hypertrophic Cardiomyopathy Group, Obstructive Hypertrophic Cardiomyopathy Group |
Primary outcome
Incidence and severity of adverse events (AEs).
Time frame: About 1 year.
Incidence of left ventricular ejection fraction (LVEF) <50%.
Time frame: About 1 year.
2 secondary outcomes
The change in cardiac troponin from baseline.
Time frame: Week 24 and Week 52.
The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.
Time frame: Week 24 and Week 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-1893 Tablet in people with Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhong Lv (+86-0518-82342973, jianhong.lv.jl9@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs). (time frame: About 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.