Ademetionine for Obstructive Hypertrophic Cardiomyopathy, Compared With Placebo
Tests ademetionine against placebo in adults with obstructive hypertrophic cardiomyopathy.
Plain-language title generated from the registry record
Registry title: Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Key facts
- Where
- Beijing, Shanghai, and Xinjiang, ChinaSee the 3 sites
- Phase
- Phase 2
Where in China
- Fuwai HospitalBeijing, ChinaTaking people
- Zhongshan Hospital, Shanghai Medical College of Fudan UniversityShanghai, ChinaTaking people
- The First Affiliated Hospital of Xinjiang Medical UniversityXinjiang, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China National Center for Cardiovascular Diseases
- Trial code
- NCT07367724
- Record updated
- 20 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Planned for any surgical (including septal reduction therapy) or interventional procedure during the trial period; Currently participation in another drug or device clinical trial; 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 use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period; History of any other disease with a life expectancy of less than 1 year; Currently pregnant or planning pregnancy.