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Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Sponsor: China National Center for Cardiovascular Diseases
Summary
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.
Official title: Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
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.
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