Ademetionine in Obstructive Hypertrophic Cardiomyopathy

Phase 2Not Yet RecruitingNCT07367724

China National Center for Cardiovascular Diseases44 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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, with Peak VO₂ ≤ 20 mL/kg/min at screening. * 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. * Known genetic defects affecting methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, vitamin B12 metabolic defects). * Current vitamin B12 or folate deficiency. * 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.