NCT07367724RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 25 Dec 2025
- Start date
- Jan 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07367724
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From Jan 2026 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned for any surgical (including septal reduction therapy) or interventional procedure during the trial period.
- Currently participation in another drug or device clinical trial.
Other illness
- 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 use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period.
- History of any other disease with a life expectancy of less than 1 year.
Other
- Currently pregnant or planning pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Zhongshan Hospital, Shanghai Medical College of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Xinjiang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.