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

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 Overview

• Status: Recruiting
• Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)
• Intervention / Treatment: Drug: Ademetionine 1,4-Butanedisulfonate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yu Zhang; Phone Number: +86 19801288531; Email: dr_yuzhang@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuwai Hospital
    • Contact: Lei Song; Phone Number: 19801288531; Email: songlqd@126.com
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital, Shanghai Medical College of Fudan University
    • Contact: Ruizhen Chen; Phone Number: 13774462136; Email: chen.ruizhen@zs-hospital.sh.cn
  • Xinjiang, China
    • Not yet recruiting
    • The First Affiliated Hospital of Xinjiang Medical University
    • Contact: Yingying Zheng; Phone Number: 15214804944; Email: zhengying527@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; The placebo is a starch tablet identical in appearance, odor, and other physical properties.
Active Comparator: Ademetionine group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pVO₂ by CPET from baseline to Week 16	From enrollment to the end of treatment at 16 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximal left ventricular wall thickness from baseline to Week 16	Exploratory endpoint	From enrollment to the end of treatment at 16 weeks
Change in NT-proBNP from baseline to Week 16	Exploratory endpoint	From enrollment to the end of treatment at 16 weeks
Change in hs-cTnI from baseline to Week 16	Exploratory endpoint	From enrollment to the end of treatment at 16 weeks
Change in hs-cTnT from baseline to Week 16	Exploratory endpoint	From enrollment to the end of treatment at 16 weeks
Change in SF-36 from baseline to Week 16	Exploratory endpoint	From enrollment to the end of treatment at 16 weeks
Change in HCMSQ from baseline to Week 16	Exploratory endpoint	From enrollment to the end of treatment at 16 weeks

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: 2025-ZX068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No