UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059669 |
|---|---|
| Receipt number | R000068255 |
| Scientific Title | Effects of Mavacamten on Coronary Microcirculation in Obstructive Hypertrophic Cardiomyopathy |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/06 18:26:54 |
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Basic information
Public title
Effects of Mavacamten on Coronary Microcirculation in Obstructive Hypertrophic Cardiomyopathy
Acronym
Effects of Mavacamten on Coronary Microcirculation in Obstructive Hypertrophic Cardiomyopathy
Scientific Title
Effects of Mavacamten on Coronary Microcirculation in Obstructive Hypertrophic Cardiomyopathy
Scientific Title:Acronym
Effects of Mavacamten on Coronary Microcirculation in Obstructive Hypertrophic Cardiomyopathy
Region
| Japan |
Condition
Condition
Obstructive Hypertrophic Cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of mavacamten on coronary microcirculation in patients with symptomatic obstructive hypertrophic cardiomyopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the change in the index of microcirculatory resistance (IMR) before and after 16 weeks of mavacamten treatment in patients with obstructive hypertrophic cardiomyopathy who have a peak left ventricular outflow tract pressure gradient 50 mmHg or higher and are in NYHA class 2 or higher.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with obstructive hypertrophic cardiomyopathy (HCM)
Patients who meet the mavacamten administration criteria described in the 2025 revised Japanese Heart Failure Guidelines (those who continue to have NYHA functional class II-III symptoms despite pharmacological therapy with beta-blockers or calcium channel blockers)
Patients with a left ventricular ejection fraction (LVEF) >=55% at rest
Patients with a peak left ventricular outflow tract (LVOT) pressure gradient >=50 mmHg at rest, during Valsalva maneuver, or during exercise
Patients who have received a sufficient explanation regarding the purpose and details of this study, have fully understood it, and have provided written informed consent of their own free will
Key exclusion criteria
Patients with a history of resuscitation after cardiac arrest
Patients with a history of syncope, sustained ventricular tachycardia, or appropriate implantable cardioverter-defibrillator (ICD) intervention within the past 6 months
Patients who have undergone surgical septal myectomy or percutaneous transluminal septal myocardial ablation (PTSMA) within the past 6 months
Patients with a history of hypersensitivity to mavacamten, severe hepatic impairment (Child-Pugh class C), or who are pregnant or possibly pregnant
Patients who refuse to participate in the study or are deemed ineligible by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Hakozaki |
Organization
KINDAI University Faculty of Medicine
Division name
Cardiovascular Medicine
Zip code
590-0197
Address
1-14-1 Mihara-dai, Minami-ku, Sakai-shi, Osaka
TEL
072-288-7222
shakozaki@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
KINDAI University Faculty of Medicine
Division name
Cardiovascular Medicine
Zip code
590-0197
Address
1-14-1 Mihara-dai, Minami-ku, Sakai-shi, Osaka
TEL
072-288-7222
Homepage URL
shakozaki@med.kindai.ac.jp
Sponsor or person
Institute
KINDAI University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiology, Kindai University
Address
1-14-1 Mihara-dai, Minami-ku, Sakai-shi, Osaka
Tel
072-288-7222
shakozaki@med.kindai.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 20 | 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 | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
Prospective observational study
Registered patients
Patients with obstructive hypertrophic cardiomyopathy treated with mavacamten
Observation items
Medical history
Blood tests
Cardiopulmonary exercise test
Echocardiography
Cardiac magnetic resonance imaging (MRI)
Cardiac catheterization
Evaluation item
Change in the index of microcirculatory resistance (IMR) before and after mavacamten treatment
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068255
