Ademetionine in Obstructive Hypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ademetionine 1,4-Butanedisulfonate
DrugAdemetionine 1,4-Butanedisulfonate is the currently available marketed oral pharmaceutical formulation of S-adenosylmethionine. Its brand name is Ximeixin in China.
Placebo
DrugThe placebo is a starch tablet identical in appearance, odor, and other physical properties.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Ademetionine groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in pVO₂ by CPET from baseline to Week 16
Time frame
From enrollment to the end of treatment at 16 weeksSecondary outcomes
1
Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16
Time frame
From enrollment to the end of treatment at 16 weeks2
Change in KCCQ-CSS from baseline to Week 16
Time frame
From enrollment to the end of treatment at 16 weeks3
Change in provoked left ventricular outflow tract gradient from baseline to Week 16
Time frame
From enrollment to the end of treatment at 16 weeks4
Change in left ventricular mass index from baseline to Week 16
Time frame
From enrollment to the end of treatment at 16 weeksOther outcomes
1
Change in maximal left ventricular wall thickness from baseline to Week 16
Exploratory endpoint
Time frame
From enrollment to the end of treatment at 16 weeks2
Change in NT-proBNP from baseline to Week 16
Exploratory endpoint
Time frame
From enrollment to the end of treatment at 16 weeks3
Change in hs-cTnI from baseline to Week 16
Exploratory endpoint
Time frame
From enrollment to the end of treatment at 16 weeks4
Change in hs-cTnT from baseline to Week 16
Exploratory endpoint
Time frame
From enrollment to the end of treatment at 16 weeksSponsors and contacts
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Source ClinicalTrials.gov