CardiomyopathyNCT07541833
Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan (MANAGE-HCM)
An observational study of Cardiomyopathy, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- Mavacamten
- How many people
- 36 participants
- Where
- 1 siteJapan
- Study dates
- 5 Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Japan1 site, 1 recruiting
- Recruiting
Mebix. Inc
Minato-ku, Tokyo, 1050001
Minoru Tonogai, Site 0001
About this study
Official title: A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Cibenzoline in Japan (MANAGE-HCM)
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan
- Conditions
- Cardiomyopathy
- Being tested
- Mavacamten
- Keywords
- hypertrophic cardiomyopathy (HOCM)
- Medical subject headings
- Cardiomyopathies, Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Switch Group | Participants who discontinue cibenzoline before or at the initiation of mavacamten treatment Receives: Drug: Mavacamten | |
| Tapering/Add-on Group | Participants who continue cibenzoline at the initiation of mavacamten treatment Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment
Measured: Baseline and up to week 16
Secondary outcomes (25)
Change in Left Ventricular Outflow Tract (LVOT) peak gradient (resting and Valsalva maneuver)
Measured: Baseline and up to week 16
Proportion of patients achieving target Left Ventricular Outflow Tract (LVOT) peak gradients (<50 mmHg / <30 mmHg) (Valsalva maneuver or post-exercise)
Measured: Baseline and up to week 16
Proportion of patients with any decrease in resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradients
Measured: Baseline and up to week 16
Proportion of patients with ≥1 New York Heart Association (NYHA) functional class improvement
Measured: Baseline and up to week 16
Change in cardiac biomarkers from baseline
Biomarkers include brain natriuretic peptide (BNP) or N-terminal prohormone of BNP (NT-proBNP)
Measured: Baseline and up to week 16
Change in systolic function parameters (left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Number of participants with Left Ventricular Ejection Fraction (LVEF) <50% as assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in left ventricular cardiac output (LVCO) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in early diastolic mitral annular velocity (e') measured at the lateral, septal, and averaged positions from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in E/e' ratio measured at the lateral, septal, and averaged positions and E/A ratio (ratio of early (E) to late (A) ventricular filling velocities) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in cardiac structural dimensions from baseline assessed by transthoracic echocardiography (TTE)
Structural dimensions include: septal thickness, posterior wall thickness, maximal left ventricular wall thickness, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and left atrial dimension
Measured: Baseline and up to week 16
Change in left ventricular outflow tract (LVOT) gradient measured at rest and during Valsalva maneuver from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in cardiac chamber volumes (left ventricular end-diastolic volume, left ventricular end-systolic volume, and left atrial volume) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in indexed cardiac chamber volumes (left ventricular end-diastolic volume index, left ventricular end-systolic volume index, and left atrial volume index) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in left ventricular diameters (left ventricular end-diastolic diameter and left ventricular end-systolic diameter) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in indexed left ventricular diameters (left ventricular end-diastolic diameter index and left ventricular end-systolic diameter index) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in left atrial dimension from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in left ventricular mass index (LVMI) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Number of participants with systolic anterior motion (SAM) of the mitral valve, and number of participants with mitral regurgitation (MR) assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Number of treatment emergent adverse events (TEAEs)/adverse drug reactions (ADRs) and serious TEAEs/ADRs
Measured: Up to week 16
Proportion of participants continuing cibenzoline
Measured: Baseline and weeks 4, 8, 12, and 16
Proportion of patients who decrease or increase dose and/or frequency of cibenzoline, beta blocker, or calcium channel blocker
Measured: Baseline and weeks 4, 8, 12, and 16
Daily dose of cibenzoline, beta blocker, or calcium channel blocker
Measured: Baseline and weeks 4, 8, 12, and 16
Change in Left Ventricular Ejection Fraction (LVEF) as assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Change in left ventricular stroke volume (LVSV) from baseline assessed by transthoracic echocardiography (TTE)
Measured: Baseline and up to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start5 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristo Myers Squibb, Study director, Bristo Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541833
- Sponsor's protocol ID
- CV027-1233
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten in Patients With Obstructive Hypertrophic Cardiomyopathy Treated With Cibenzoline in Japan (MANAGE-HCM)
- ClinicalTrials.gov ID
- NCT07541833
- Acronym / sponsor ID
- CV027-1233
- Conditions
- Cardiomyopathy
- Keywords
- hypertrophic cardiomyopathy (HOCM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch Group | – | Drug: MavacamtenParticipants who discontinue cibenzoline before or at the initiation of mavacamten treatment |
| Tapering/Add-on Group | – | Drug: MavacamtenParticipants who continue cibenzoline at the initiation of mavacamten treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (11 listed)
- 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 documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline.
- Participants who meet any of the following criteria:
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MavacamtenAccording to the product label | Drug | Switch Group, Tapering/Add-on Group |
Primary outcome
Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment
Time frame: Baseline and up to week 16
25 secondary outcomes
Change in Left Ventricular Outflow Tract (LVOT) peak gradient (resting and Valsalva maneuver)
Time frame: Baseline and up to week 16
Proportion of patients achieving target Left Ventricular Outflow Tract (LVOT) peak gradients (<50 mmHg / <30 mmHg) (Valsalva maneuver or post-exercise)
Time frame: Baseline and up to week 16
Proportion of patients with any decrease in resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradients
Time frame: Baseline and up to week 16
Proportion of patients with ≥1 New York Heart Association (NYHA) functional class improvement
Time frame: Baseline and up to week 16
Change in cardiac biomarkers from baseline
Time frame: Baseline and up to week 16
Change in systolic function parameters (left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Number of participants with Left Ventricular Ejection Fraction (LVEF) <50% as assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in left ventricular cardiac output (LVCO) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in early diastolic mitral annular velocity (e') measured at the lateral, septal, and averaged positions from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in E/e' ratio measured at the lateral, septal, and averaged positions and E/A ratio (ratio of early (E) to late (A) ventricular filling velocities) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in cardiac structural dimensions from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in left ventricular outflow tract (LVOT) gradient measured at rest and during Valsalva maneuver from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in cardiac chamber volumes (left ventricular end-diastolic volume, left ventricular end-systolic volume, and left atrial volume) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in indexed cardiac chamber volumes (left ventricular end-diastolic volume index, left ventricular end-systolic volume index, and left atrial volume index) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in left ventricular diameters (left ventricular end-diastolic diameter and left ventricular end-systolic diameter) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in indexed left ventricular diameters (left ventricular end-diastolic diameter index and left ventricular end-systolic diameter index) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in left atrial dimension from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in left ventricular mass index (LVMI) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Number of participants with systolic anterior motion (SAM) of the mitral valve, and number of participants with mitral regurgitation (MR) assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Number of treatment emergent adverse events (TEAEs)/adverse drug reactions (ADRs) and serious TEAEs/ADRs
Time frame: Up to week 16
Proportion of participants continuing cibenzoline
Time frame: Baseline and weeks 4, 8, 12, and 16
Proportion of patients who decrease or increase dose and/or frequency of cibenzoline, beta blocker, or calcium channel blocker
Time frame: Baseline and weeks 4, 8, 12, and 16
Daily dose of cibenzoline, beta blocker, or calcium channel blocker
Time frame: Baseline and weeks 4, 8, 12, and 16
Change in Left Ventricular Ejection Fraction (LVEF) as assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Change in left ventricular stroke volume (LVSV) from baseline assessed by transthoracic echocardiography (TTE)
Time frame: Baseline and up to week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristo Myers Squibb study director
Bristo Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment (time frame: Baseline and up to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.