Ademetionine treatment for obstructive hypertrophic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dr_yuzhang@126.com
• Phone: +86 19801288531

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.