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RECRUITINGPhase 2INTERVENTIONAL

Ademetionine in Obstructive Hypertrophic Cardiomyopathy

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form and comply with all scheduled study visits. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (3)

Fuwai Hospital
Beijing, China
Zhongshan Hospital, Shanghai Medical College of Fudan University
Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China