Obstructive Hypertrophic Cardiomyopathy (oHCM)Phase 2NCT07367724
Ademetionine in Obstructive Hypertrophic Cardiomyopathy
A Phase 2 study testing Ademetionine 1,4-Butanedisulfonate in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial summary
This study is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Ademetionine 1,4-Butanedisulfonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2026to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for HCM.
- Age ≥ 18 years at screening.
- LVEF ≥ 50% at screening.
- Echocardiography demonstrates a resting or provoked LVOTG ≥ 30 mmHg at screening.
- NYHA Functional Class II-III at screening.
- Able to perform CPET.
- Patients receiving treatment with β-blockers or non-dihydropyridine calcium channel blockers should have been on a stable dose for at least 6 weeks prior to randomization and are expected to maintain the same medication during the trial. Who have previously received cardiac myosin inhibitors (e.g., Mavacamten) must discontinue the treatment for at least 8 weeks prior to randomization.
- Willing and able to sign the informed consent form and comply with all scheduled study visits.
Who cannot join
- History of severe hypersensitivity to any component of Ademetionine 1,4-Butanedisulfonate Enteric-coated Tablets.
- History of psychiatric disorders, or current use of antidepressants such as clomipramine.
- Planned for any surgical (including septal reduction therapy) or interventional procedure during the trial period.
- Planned use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period.
- Currently pregnant or planning pregnancy.
- Currently participation in another drug or device clinical trial.
- History of any other disease with a life expectancy of less than 1 year.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Fuwai Hospital
Beijing
Lei Song, 19801288531, songlqd@126.com
- Recruiting
Zhongshan Hospital, Shanghai Medical College of Fudan University
Shanghai
Ruizhen Chen, 13774462136, chen.ruizhen@zs-hospital.sh.cn
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang
Yingying Zheng, 15214804944, zhengying527@163.com
About this study
Official title: Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study
This study is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). The study will recruit patients with oHCM who, under double-blind conditions, will be randomly assigned to either the Ademetionine group or the placebo group. Follow-up visits will be conducted every 4 weeks until 16 weeks from baseline. After 16 weeks, the study will evaluating the effect of Ademetionine on exercise capacity, heart failure symptoms, cardiac structure and function, and quality of life, as well as safety and tolerability of Ademetionine in this patient population.
- Being tested
- Ademetionine 1,4-Butanedisulfonate, Placebo
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ademetionine 1,4-ButanedisulfonateDrug
Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.
PlaceboDrug
The placebo is a starch tablet identical in appearance, odor, and other physical properties.
| Study group | Role | What they receive |
|---|---|---|
| Ademetionine group | Active comparator | Not described Receives: Drug: Ademetionine 1,4-Butanedisulfonate |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pVO₂ by CPET from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (7)
Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Change in KCCQ-CSS from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Change in provoked left ventricular outflow tract gradient from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Change in left ventricular mass index from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Change in left atrial volume index from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Change in E/e' from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Change in VE/VCO₂ slope by CPET from baseline to Week 16
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367724
- Sponsor's protocol ID
- 2025-ZX068
- Status last verified
- Mar 2026
- First submitted
- 25 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study
- ClinicalTrials.gov ID
- NCT07367724
- Acronym / sponsor ID
- 2025-ZX068
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 2026 (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 is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). The study will recruit patients with oHCM who, under double-blind conditions, will be randomly assigned to either the Ademetionine group or the placebo group. Follow-up visits will be conducted every 4 weeks until 16 weeks from baseline. After 16 weeks, the study will evaluating the effect of Ademetionine on exercise capacity, heart failure symptoms, cardiac structure and function, and quality of life, as well as safety and tolerability of Ademetionine in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ademetionine group | Active comparator | Drug: Ademetionine 1,4-Butanedisulfonate |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the diagnostic criteria for HCM.
- Age ≥ 18 years at screening.
- LVEF ≥ 50% at screening.
- Echocardiography demonstrates a resting or provoked LVOTG ≥ 30 mmHg at screening.
- NYHA Functional Class II-III at screening.
Key exclusion criteria (7 listed)
- History of severe hypersensitivity to any component of Ademetionine 1,4-Butanedisulfonate Enteric-coated Tablets.
- History of psychiatric disorders, or current use of antidepressants such as clomipramine.
- Planned for any surgical (including septal reduction therapy) or interventional procedure during the trial period.
- Planned use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period.
- Currently pregnant or planning pregnancy.
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 |
|---|---|---|
| Ademetionine 1,4-ButanedisulfonateAdemetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China. | Drug | Ademetionine group |
| PlaceboThe placebo is a starch tablet identical in appearance, odor, and other physical properties. | Drug | Placebo group |
Primary outcome
Change in pVO₂ by CPET from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
7 secondary outcomes
Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
Change in KCCQ-CSS from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
Change in provoked left ventricular outflow tract gradient from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
Change in left ventricular mass index from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
Change in left atrial volume index from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
Change in E/e' from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 weeks
Change in VE/VCO₂ slope by CPET from baseline to Week 16
Time frame: From enrollment to the end of treatment at 16 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 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)
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RecruitingPhase 3
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
Cardiomyopathy, Hypertrophic Obstructive
Active, not recruitingObservational study
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Active, not recruitingObservational study
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Hypertrophic Cardiomyopathy (HCM)
Not yet recruitingObservational study
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ademetionine 1,4-Butanedisulfonate in people with Obstructive Hypertrophic Cardiomyopathy (oHCM), run by China National Center for Cardiovascular Diseases at 3 sites 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 8 inclusion and 7 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 Yu Zhang (+86 19801288531, dr_yuzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pVO₂ by CPET from baseline to Week 16 (time frame: From enrollment to the end of treatment at 16 weeks). 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 20 Mar 2026.