UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058173 |
|---|---|
| Receipt number | R000066482 |
| Scientific Title | Impact of mavacamten on microvascular resistance in patents with obstructive hypertrophic cardiomyopathy |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/13 17:44:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of mavacamten on microvascular resistance in patents with obstructive hypertrophic cardiomyopathy
Acronym
Impact of mavacamten on microvascular resistance in patents with obstructive hypertrophic cardiomyopathy
Scientific Title
Impact of mavacamten on microvascular resistance in patents with obstructive hypertrophic cardiomyopathy
Scientific Title:Acronym
Impact of mavacamten on microvascular resistance in patents with obstructive hypertrophic cardiomyopathy
Region
| Japan |
Condition
Condition
Obstructive hyperthrophic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of mavacamten on coronary microvascular dysfunction in symptomtic patients with obstructive hypertrophic cardiomyopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in index of microvascular resistance (IMR) between pre and post treatment of mavacamten
Key secondary outcomes
1. Changes in coronary flow reserve
2. Changes in right heart catheterization
3. Relationship between changes in IMR and echocardiographic parameters
4. Relationship between changes in IMR and cardiac magnetic resonance imaging
5. Relationship between changes in IMR and right heart catheterization
6. Relationship between changes in IMR and changes in left ventricular outflow tract gradient
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals diagnosed with obstructive hypertrophic cardiomyopathy.
2. Individuals who exhibit NYHA functional class II or III symptoms despite receiving standard pharmacological therapies, including beta-blockers, calcium channel blockers, or sodium channel blockers.
3. Individuals with a resting LVEF of 55% or over.
4. Individuals with a resting peak LVOT pressure gradient of 30 mm Hg or over.
5. Individuals who have received a thorough explanation of the study, demonstrated sufficient understanding, and provided written informed consent voluntarily.
Key exclusion criteria
1. Individuals who have expressed a desire to decline participation in the study.
2. Individuals who are deemed by the principal investigator to be inappropriate for participation in the study for any other reason.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81-72-366-0221
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Junna |
| Middle name | |
| Last name | Takuwa |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Cardiology
Zip code
5898511
Address
377-2, Ohnohigashi, Osakasayama
TEL
+81-72-366-0221
Homepage URL
083887@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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiology, Kindai Univeristy, Faculty of Medicine
Address
377-2, Ohnohigashi, Osakasayama
Tel
+81-72-366-0221
kmatsumura1980@yahoo.co.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 | 06 | Month | 13 | 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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2025 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066482
