Obstructive Hypertrophic CardiomyopathyPhase 2NCT06516068
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
A Phase 2 study testing HRS-1893 in people with Obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2024to Aug 2025
- 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
- Age 18-85 years old, gender unlimited;
- The diagnosis was obstructive hypertrophic cardiomyopathy.
- Echocardiographic laboratory tests showed LVEF≥60%;
- No previous left ventricular systolic dysfunction at any time (LVEF < 45%);
- Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
Who cannot join
- Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM);
- Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF < 45%);
- Previous history of aortic stenosis or subaortic fixed stenosis;
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, 100032
About this study
Official title: A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- HRS-1893
- 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-1893Drug
HRS-1893
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 | Experimental | Not described Receives: Drug: HRS-1893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver
Measured: After 12 weeks of HRS-1893 treatment
Secondary outcomes (13)
Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)
Measured: Baseline to Week 12
Change in LVEF
Measured: Baseline to Week 12
Change in LVOT-VTI
Measured: Baseline to Week 12
Change in LV-FS
Measured: Baseline to Week 12
Change in LV-GLS
Measured: Baseline to Week 12
Change in Rest LVOT-G
Measured: Baseline to Week 12
Change in Valsalva LVOT-G
Measured: Baseline to Week 12
Change in cardiac troponin
Measured: Baseline to Week 12
Change in NT-proBNP
Measured: Baseline to Week 12
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Measured: Baseline to Week 12
Proportion of participants with ≥ 1 class improvement in NYHA Functional Class
Measured: Baseline to Week 12
Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)
Measured: Through study completion, an average of 68 weeks
plasma concentration of HRS-1893
Measured: Through study completion, an average of 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start11 Aug 2024
- Primary completion18 Nov 2024
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
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
- NCT06516068
- Sponsor's protocol ID
- HRS-1893-201
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2024
- Last updated
- 16 Jul 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.
- ClinicalTrials.gov ID
- NCT06516068
- Acronym / sponsor ID
- HRS-1893-201
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Jul 2024 (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.
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 | Experimental | Drug: HRS-1893 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-85 years old, gender unlimited;
- The diagnosis was obstructive hypertrophic cardiomyopathy.
- Echocardiographic laboratory tests showed LVEF≥60%;
- No previous left ventricular systolic dysfunction at any time (LVEF < 45%);
- Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
Key exclusion criteria (3 listed)
- Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM);
- Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF < 45%);
- Previous history of aortic stenosis or subaortic fixed stenosis;
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-1893HRS-1893 | Drug | HRS-1893 |
Primary outcome
The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver
Time frame: After 12 weeks of HRS-1893 treatment
13 secondary outcomes
Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)
Time frame: Baseline to Week 12
Change in LVEF
Time frame: Baseline to Week 12
Change in LVOT-VTI
Time frame: Baseline to Week 12
Change in LV-FS
Time frame: Baseline to Week 12
Change in LV-GLS
Time frame: Baseline to Week 12
Change in Rest LVOT-G
Time frame: Baseline to Week 12
Change in Valsalva LVOT-G
Time frame: Baseline to Week 12
Change in cardiac troponin
Time frame: Baseline to Week 12
Change in NT-proBNP
Time frame: Baseline to Week 12
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Time frame: Baseline to Week 12
Proportion of participants with ≥ 1 class improvement in NYHA Functional Class
Time frame: Baseline to Week 12
Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)
Time frame: Through study completion, an average of 68 weeks
plasma concentration of HRS-1893
Time frame: Through study completion, an average of 68 weeks
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 16 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Obstructive 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver (time frame: After 12 weeks of HRS-1893 treatment). 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 16 Jul 2025.