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NCT Number: NCT07367724

Ademetionine in Obstructive Hypertrophic Cardiomyopathy

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.

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Key information

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM) Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fuwai Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ademetionine 1,4-Butanedisulfonate

Drug

Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.

Placebo

Drug

The placebo is a starch tablet identical in appearance, odor, and other physical properties.

Primary outcomes

  1. Change in pVO₂ by CPET from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

Secondary outcomes

  1. Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  2. Change in KCCQ-CSS from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  3. Change in provoked left ventricular outflow tract gradient from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  4. Change in left ventricular mass index from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  5. Change in left atrial volume index from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  6. Change in E/e' from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

  7. Change in VE/VCO₂ slope by CPET from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

Other outcomes

  1. Change in maximal left ventricular wall thickness from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

    Exploratory endpoint

  2. Change in NT-proBNP from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

    Exploratory endpoint

  3. Change in hs-cTnI from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

    Exploratory endpoint

  4. Change in hs-cTnT from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

    Exploratory endpoint

  5. Change in SF-36 from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

    Exploratory endpoint

  6. Change in HCMSQ from baseline to Week 16

    Time frame: From enrollment to the end of treatment at 16 weeks

    Exploratory endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Zhang

CONTACT

[email protected]

+86 19801288531

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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