Ademetionine in Obstructive Hypertrophic Cardiomyopathy

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in pVO₂ by CPET from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]

Вторичные конечные точки (7)

• Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]
• Change in KCCQ-CSS from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]
• Change in provoked left ventricular outflow tract gradient from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]
• Change in left ventricular mass index from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]
• Change in left atrial volume index from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]
• Change in E/e' from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]
• Change in VE/VCO₂ slope by CPET from baseline to Week 16 [Срок оценки: From enrollment to the end of treatment at 16 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Fuwai Hospital — Пекин
• Zhongshan Hospital, Shanghai Medical College of Fudan University — Шанхай
• The First Affiliated Hospital of Xinjiang Medical University — Xinjiang

Идентификаторы

NCT: NCT07367724 · 2025-ZX068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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