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New treatment option for Obstructive Hypertrophic Cardiomyopathy (oHCM)
Official title Ademetionine in Obstructive Hypertrophic Cardiomyopathy
ClinicalTrials.gov ID: NCT07367724
What this study is testing
What is Ademetionine 1,4-Butanedisulfonate?
Ademetionine 1,4-Butanedisulfonate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for obstructive hypertrophic cardiomyopathy (ohcm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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 treatment 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.
See the full eligibility 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...
- Willing and able to sign the informed consent form and comply with all scheduled study visits.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Shanghai, China
- Xinjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Shanghai, China; Xinjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.