Obstructive Hypertrophic Cardiomyopathy (oHCM)
Conditions
Brief 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). 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.
Interventions
Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.
DRUGPlacebo
The placebo is a starch tablet identical in appearance, odor, and other physical properties.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pVO₂ by CPET from baseline to Week 16 | From enrollment to the end of treatment at 16 weeks |
Secondary
| Measure | 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 |
| 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 |
Countries
China
Contacts
CONTACTYu Zhang
Outcome results
None listed