Ademetionine in Obstructive Hypertrophic Cardiomyopathy (NCT07367724) | Clinical Trial Compass
RecruitingPhase 2
Ademetionine in Obstructive Hypertrophic Cardiomyopathy
China44 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pVO₂ by CPET from baseline to Week 16
Timeframe: From enrollment to the end of treatment at 16 weeks
Trial details
NCT IDNCT07367724
SponsorChina National Center for Cardiovascular Diseases