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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ademetionine group | Active Comparator |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ademetionine 1,4-Butanedisulfonate | Drug | Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pVO₂ by CPET from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks | |
| Change in KCCQ-CSS from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximal left ventricular wall thickness from baseline to Week 16 | Exploratory endpoint | From enrollment to the end of treatment at 16 weeks |
| Change in NT-proBNP from baseline to Week 16 | Exploratory endpoint |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Zhang | Contact | +86 19801288531 | dr_yuzhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| Placebo | Drug | The placebo is a starch tablet identical in appearance, odor, and other physical properties. |
|
| Change in provoked left ventricular outflow tract gradient from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| Change in left ventricular mass index from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| Change in left atrial volume index from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| Change in E/e' from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| Change in VE/VCO₂ slope by CPET from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
| From enrollment to the end of treatment at 16 weeks |
| Change in hs-cTnI from baseline to Week 16 | Exploratory endpoint | From enrollment to the end of treatment at 16 weeks |
| Change in hs-cTnT from baseline to Week 16 | Exploratory endpoint | From enrollment to the end of treatment at 16 weeks |
| Change in SF-36 from baseline to Week 16 | Exploratory endpoint | From enrollment to the end of treatment at 16 weeks |
| Change in HCMSQ from baseline to Week 16 | Exploratory endpoint | From enrollment to the end of treatment at 16 weeks |
| Zhongshan Hospital, Shanghai Medical College of Fudan University | Recruiting | Shanghai | China |
|
| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Xinjiang | China |
|
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |