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Recruiting NCT07367724

Ademetionine in Obstructive Hypertrophic Cardiomyopathy

Phase II Interventional Obstructive Hypertrophic Cardiomyopathy (oHCM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ademetionine 1,4-Butanedisulfonate, Placebo.
Who it may be relevant to
Registry conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Ademetionine 1,4-Butanedisulfonate
    Ademetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.
  • Drug Placebo
    The placebo is a starch tablet identical in appearance, odor, and other physical properties.

Primary outcome measures

  • Change in pVO₂ by CPET from baseline to Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
Secondary outcome measures (7)
  • 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]
  • Change in KCCQ-CSS from baseline to Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
  • 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]
  • Change in left ventricular mass index from baseline to Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
  • Change in left atrial volume index from baseline to Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
  • Change in E/e' from baseline to Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]
  • Change in VE/VCO₂ slope by CPET from baseline to Week 16 [Time frame: From enrollment to the end of treatment at 16 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • Fuwai Hospital — Beijing
  • Zhongshan Hospital, Shanghai Medical College of Fudan University — Shanghai
  • The First Affiliated Hospital of Xinjiang Medical University — Xinjiang

Identifiers

NCT: NCT07367724 · 2025-ZX068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗