UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056061 |
|---|---|
| Receipt number | R000064037 |
| Scientific Title | Study on the progression of idiopathic dilated cardiomyopathy over time by cardiac MRI |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/05 18:14:03 |
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Basic information
Public title
Study on the progression of idiopathic dilated cardiomyopathy over time by cardiac MRI
Acronym
DCM-REPEAT-MRI study
Scientific Title
Study on the progression of idiopathic dilated cardiomyopathy over time by cardiac MRI
Scientific Title:Acronym
DCM-REPEAT-MRI study
Region
| Japan |
Condition
Condition
Idiopathic Dilated Cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to investigate changes in ventricular myocardial fibrosis over time in idiopathic dilated cardiomyopathy and clarify the relationship between fibrosis and therapeutic effects and prognosis.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate changes in ventricular myocardial fibrosis over time in idiopathic dilated cardiomyopathy using repeated cardiac MRI.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of longitudinal changes in cardiac function and myocardial fibrosis in idiopathic dilated cardiomyopathy
Key secondary outcomes
Mortality, cardiovascular event rate, treatment, presence of genetic abnormalities, and their association with changes in cardiac function and myocardial fibrosis overtime during the observation period.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Myocardial fibrosis will be assessed by cardiac MRI in patients with idiopathic dilated cardiomyopathy at the beginning of enrollment and at 2 and 5 years after enrollment. In addition, the presence or absence of cardiovascular events and treatment during the observation period will be collected.
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. Age 18 years and older
2. Diagnosed with idiopathic dilated cardiomyopathy
3. Subjects who have undergone cardiac MRI to evaluate myocardial fibrosis (within 1 month from the time of enrollment)
Key exclusion criteria
1. Patients with contraindications to MRI examinations.
2. Patients with a history of serious allergic reactions to previous contrast CT or MRI examinations.
3. Patients with reduced systolic function that cannot be ruled out concerning coronary artery disease.
4. Patients with hypertrophic cardiomyopathy.
5. Patients with arrhythmogenic right ventricular cardiomyopathy.
6. Patients with valvular cardiomyopathy.
7. Patients with primary congenital heart disease (excluding cardiomyopathy).
8. Patients with acute myocarditis.
9. Patients not reasonably expected to survive longer than 1 year.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | John |
| Last name | Akashi |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111
johnny@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Ikutaro |
| Middle name | |
| Last name | Nakajima |
Organization
St. Marianna University School of Medicine
Division name
Department of Cardiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL
044-977-8111(3313)
Homepage URL
ikutaro0817@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research-KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine IRB
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel
044-977-8111(4052)
k-sienbu.mail@marianna-u.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
| 2024 | Year | 11 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064037
