Actively Recruiting
Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Led by China National Center for Cardiovascular Diseases · Updated on 2026-03-20
44
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for hypertrophic cardiomyopathy (HCM).
- Be 18 years of age or older at screening.
- Have a left ventricular ejection fraction (LVEF) of 50% or greater at screening.
- Show resting or provoked left ventricular outflow tract gradient (LVOTG) of 30 mmHg or higher by echocardiography at screening.
- Be classified as New York Heart Association (NYHA) Functional Class II or III at screening.
- Be able to perform cardiopulmonary exercise testing (CPET).
- If receiving beta-blockers or non-dihydropyridine calcium channel blockers, have been on a stable dose for at least 6 weeks before randomization and plan to maintain the same medication during the trial.
- If previously treated with cardiac myosin inhibitors (e.g., Mavacamten), have discontinued use for at least 8 weeks before randomization.
- Be willing and able to sign the informed consent form and follow all scheduled study visits.
You will not qualify if you...
- History of severe allergic reaction to any component of Ademetionine 1,4-Butanedisulfonate enteric-coated tablets.
- History of psychiatric disorders or current use of antidepressants such as clomipramine.
- Planned surgical or interventional procedures, including septal reduction therapy, during the trial period.
- Planned use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period.
- Currently pregnant or planning to become pregnant.
- Currently participating in another drug or device clinical trial.
- History of any disease with a life expectancy of less than one year.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Fuwai Hospital
Beijing, China
Actively Recruiting
2
Zhongshan Hospital, Shanghai Medical College of Fudan University
Shanghai, China
Actively Recruiting
3
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Not Yet Recruiting
Research Team
Y
Yu Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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