Ademetionine treatment for obstructive hypertrophic cardiomyopathy

Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study

This study will test whether taking ademetionine can improve exercise capacity, symptoms, heart structure and quality of life in adults with obstructive hypertrophic cardiomyopathy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT07367724 on ClinicalTrials.gov

What this trial studies

This is a multicenter, double-blind, randomized, placebo-controlled Phase 2 trial enrolling adults with obstructive hypertrophic cardiomyopathy. Participants who meet entry criteria will be randomly assigned to receive ademetionine or placebo and followed every 4 weeks for 16 weeks. Key measurements include cardiopulmonary exercise testing, assessment of heart failure symptoms (NYHA), imaging of cardiac structure and function, quality-of-life questionnaires, and safety/tolerability monitoring. Concomitant stable beta-blocker or non-dihydropyridine calcium-channel blocker therapy is allowed, and prior myosin inhibitor use must be discontinued per protocol before randomization.

Who should consider this trial

Good fit: Adults (≥18) with a clinical diagnosis of obstructive HCM, LVEF ≥50%, resting or provoked LVOT gradient ≥30 mmHg, NYHA class II–III, able to perform CPET, and on a stable dose of allowed heart-rate–controlling medications are the intended participants.

Not a fit: Patients with known severe hypersensitivity to ademetionine components, certain psychiatric disorders or taking contraindicated antidepressants, those unable to perform exercise testing, or with reduced LVEF are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, ademetionine could reduce outflow obstruction and improve exercise tolerance, symptoms, cardiac function, and quality of life for people with obstructive HCM.

How similar studies have performed: Using ademetionine for obstructive HCM is a novel approach and there is limited prior evidence supporting its benefit in this specific condition.

Eligibility criteria

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.

Where this trial is running

Beijing and 2 other locations

• Fuwai Hospital — Beijing, China (Recruiting)
• Zhongshan Hospital, Shanghai Medical College of Fudan University — Shanghai, China (Recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Xinjiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yu Zhang

Conditions Obstructive Hypertrophic Cardiomyopathy