Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study
China National Center for Cardiovascular Diseases
44 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria7
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.
The placebo is a starch tablet identical in appearance, odor, and other physical properties.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07367724