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
Qualifiers
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
Treatments tested in this trial
- Ademetionine 1,4-Butanedisulfonate
- Placebo
Treatment groups
44 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov