UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060066 |
|---|---|
| Receipt number | R000068695 |
| Scientific Title | A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten In Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Cibenzoline in Japan |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/12/12 14:02:31 |
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Basic information
Public title
A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten In Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Cibenzoline in Japan
Acronym
MANAGE-HCM
Scientific Title
A Study Evaluating Effectiveness and Treatment Patterns of Mavacamten In Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Cibenzoline in Japan
Scientific Title:Acronym
MANAGE-HCM
Region
| Japan |
Condition
Condition
Hypertrophic obstructive cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of a 16-week course of mavacamten treatment in reducing the resting or Valsalva left ventricular outflow tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in either resting or Valsalva LVOT peak gradient whichever used to judge the initiation of mavacamten treatment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Signed informed consent form (ICF):
Patients, 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.
2.Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below:
i.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).
ii.Has LVOT peak gradient >= 30 mmHg (resting, Valsalva maneuver, or post-exercise).
3.Has documented LVEF >= 55% at baseline.
4.Patients who meet any of the following criteria:
i.Patients who have previously received mavacamten continuously for >= 16 weeks
ii.Patients who are currently receiving mavacamten
iii.Patients who are scheduled to receive mavacamten
5.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.
6.At least 18 years of age at the time of signing the informed consent.
Key exclusion criteria
1.Hypersensitivity to the active substance or to any of the excipients.
2.During pregnancy and in women of childbearing potential.
3.Treated with strong CYP3A4 inhibitors (itraconazole, clarithromycin, voriconazole, posaconazole, ritonavir, cobicistat, ceritinib, ensitrelvir fumaric acid, lonafarnib, josamycin, or mifepristone/misoprostol).
4.Severe hepatic impairment (Child-Pugh C).
5.Severe atrioventricular block or severe sinoatrial block.
6.Congestive HF.
7.Requiring dialysis.
8.Angle-closure glaucoma.
9.Tendency to urinary retention.
10.Treated with vardenafil hydrochloride hydrate, moxifloxacin hydrochloride, lascufloxacin hydrochloride (injection), toremifene citrate, fingolimod hydrochloride, siponimod fumarate, or eliglustat tartrate.
11.Mavacamten treatment within 8 weeks prior to baseline.
12.Mavacamten treatment initiation was judged based on post-exercise LVOT peak gradient.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Nishinaga |
| Middle name | |
| Last name | Hiromi |
Organization
Bristol-Myers Squibb K.K.
Division name
Cardiovascular, Japan Medical
Zip code
100-0004
Address
1-2-1 Otemachi, Chiyoda-ku, Tokyo
TEL
03-6705-7000
hiromi.nishinaga@bms.com
Public contact
Name of contact person
| 1st name | Kobayashi |
| Middle name | |
| Last name | Rina |
Organization
Mebix, Inc.
Division name
Research Promotion Headquarters
Zip code
105-0001
Address
10F, Toranomon 33 Mori Building 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-4362-4500
Homepage URL
HCM_prospective_study@mebix.co.jp
Sponsor or person
Institute
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Research Ethics Committee
Address
#401, 5-20-9 Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山形大学医学部附属病院（山形県）
国立循環器病研究センター（大阪府）
熊本大学病院（熊本県）
鹿児島大学病院（鹿児島県）
高知大学医学部附属病院（高知県）
金沢医科大学病院（石川県）
日本医科大学付属病院（東京都）
名古屋市立大学（名古屋）
慶應義塾大学病院（東京都）
広島大学病院（広島県）
京都大学医学部附属病院（京都府）
和歌山県立医科大学附属病院（和歌山県）
喜多医師会病院（愛媛県）
香川大学医学部附属病院（香川県）
新潟大学医歯学総合病院（新潟県）
奈良県立医科大学附属病院（奈良県）
防衛医科大学校病院（埼玉県）
大分大学医学部附属病（大分県）
刈谷豊田総合病院（愛知県）
埼玉医科大学総合医療センター（埼玉県）
愛媛大学医学部附属病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study evaluates the initiation of mavacamten and cibenzoline usage patterns as primary factors in HOCM patients. The primary outcome is the "change in LVOT peak gradient" at Week 16, with secondary assessments including symptom improvement and safety.
It is a non-interventional observational study. The design is a prospective and retrospective cohort following patients for 16 weeks from treatment initiation. Baseline data may be collected starting three months prior.
The study employs consecutive enrollment of patients treated in routine practice, rather than random sampling. It forms a treatment-based cohort reflecting real-world settings, distinct from case-control sampling.
Management information
Registered date
| 2025 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068695
