UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043062 |
|---|---|
| Receipt number | R000049166 |
| Scientific Title | HE4, yamamotoM |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2021/01/20 12:01:06 |
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Basic information
Public title
HE4, yamamotoM
Acronym
HE4, yamamotoM
Scientific Title
HE4, yamamotoM
Scientific Title:Acronym
HE4, yamamotoM
Region
| Japan |
Condition
Condition
dilated cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical utility of HE4 measurement in patients with DCM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The study endpoint was a composite of all-cause death, left ventricular assist device (LVAD) implantation, and hospitalization for HF events. Furthermore, composite of all-cause death and LVAD implantation were defined as hard endpoint.
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
| 21 | years-old | <= |
Age-upper limit
| 86 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DCM
Key exclusion criteria
Tumor-bearing and HD
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine, Faculty of Life Sciences
Zip code
8608556
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto
TEL
+81963735175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Hanatani |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine, Faculty of Life Sciences
Zip code
8608556
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto
TEL
+81963735175
Homepage URL
s-hanata@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Kumamoto University
Address
1-1-1, Honjyo, Chuo-ku, Kumamoto
Tel
+81963735175
yamamo-m@kumamoto-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
| 2021 | Year | 01 | 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
87
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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We measured serum HE4 levels of 87 patients with DCM and followed their echocardiographic parameters and cardiovascular events.
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049166
