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Ademetionine in Obstructive Hypertrophic Cardiomyopathy

StatusRecruiting
PhasePhase 2
Started2026-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-03-18
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→3
Eligibility criteria+117 characters
[...] A Functional Class II-III at screening. Able to perform CPET,. Patients receiving treatment with Peakβ-blockers VO₂or ≤non-dihydropyridine 20calcium mL/kg/minchannel blockers should have been on a stable dose for at screeningleast 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 compl [...] Ademetionine 1,4-Butanedisulfonate Enteric-coated Tablets. K [...] [...]
2026-01-19
Original filing
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.
Trial Details
NCT Number NCT07367724
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Obstructive Hypertrophic Cardiomyopathy (oHCM)
Enrollment 44 participants
Start Date 2026-01-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-20