New heart drug mavacamten tested in japanese patients
NCT ID NCT07541833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a drug called mavacamten in adults with a type of heart disease called obstructive hypertrophic cardiomyopathy (HOCM) in Japan. The goal is to see if mavacamten can improve heart function and symptoms when added to their current treatment. About 36 participants will be followed to check safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mavacamten
- What this could lead to
- If successful, this could provide a new treatment option for people with obstructive hypertrophic cardiomyopathy in Japan, potentially improving heart function and daily symptoms.
- What could go wrong
- This is a small, early-phase study with only 36 participants, so results may not apply to everyone. The drug may cause side effects or not work as well as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) who have been prescribed mavacamten treatment by the treating physician as part of routine clinical care, in Japan
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: • Signed informed consent form (ICF): Participants, or their legally acceptable representative, must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory, local, and institutional guidelines. This must be obtained before the performance of any protocol-related procedures. * Diagnosed with obstructive hypertrophic cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below: * Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of HCM). * Has Left Ventricular Outflow Tract (LVOT) peak gradient ≥ 30 mmHg (resting, Valsalva maneuver, or post-exercise). * Has documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline. * Participants who meet any of the following criteria: * Participants who have previously received mavacamten continuously for ≥ 16 weeks * Participants who are currently receiving mavacamten * Participants who are scheduled to receive mavacamten * Treated with a stable dose of cibenzoline for at least 3 months prior to initiating mavacamten treatment. Tapered cibenzoline within 3 months prior to initiating mavacamten treatment is allowed if stable dose of cibenzoline was used for at least 3 months prior to tapering. * At least 18 years of age at the time of signing the informed consent. Exclusion Criteria: * Hypersensitivity to the active substance or to any of the excipients. * During pregnancy and in women of childbearing potential. * Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone/misoprostol). * Severe hepatic impairment (Child-Pugh C). * Severe atrioventricular block or severe sinoatrial block. * Congestive heart failure. * Requiring dialysis. * Angle-closure glaucoma. * Tendency to urinary retention. * Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate. * Mavacamten treatment within 8 weeks prior to baseline. Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mebix. Inc
RECRUITINGMinato-ku, Tokyo, 1050001, Japan
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