Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Obstructive Hypertrophic Cardiomyopathy (oHCM)
In brief
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.
Key facts
- Study ID
- NCT07367724
- Run by
- China National Center for Cardiovascular Diseases
- People needed
- 44
- Starts
- 2026-01-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fuwai Hospital — Beijing, China (enrolling)
- Zhongshan Hospital, Shanghai Medical College of Fudan University — Shanghai, China (enrolling)
- The First Affiliated Hospital of Xinjiang Medical University — Xinjiang, China
Full record on ClinicalTrials.gov
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