UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013609 |
|---|---|
| Receipt number | R000015895 |
| Scientific Title | Effects of eicosapentaenoic acid on left ventricular function in patients with nonischemic cardiomyopathy |
| Date of disclosure of the study information | 2014/04/02 |
| Last modified on | 2019/04/06 17:55:28 |
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Basic information
Public title
Effects of eicosapentaenoic acid on left ventricular function in patients with nonischemic cardiomyopathy
Acronym
Effects of eicosapentaenoic acid to nonischemic cardiomyopathy
Scientific Title
Effects of eicosapentaenoic acid on left ventricular function in patients with nonischemic cardiomyopathy
Scientific Title:Acronym
Effects of eicosapentaenoic acid to nonischemic cardiomyopathy
Region
| Japan |
Condition
Condition
chronic heart failure due to nonischemic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of eicosapentaenoic acid in patients with chronic heart failure due to nonischemic cardiomyopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical sign
biomarker
left ventricular function
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dose:EPA 1800mg
Duration:6 months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who agree a participation in this study by a document
2. Patients with chronic heart failure due to nonischemic cardiomyopathy
3. Patients who are more than 20-year-old and under 80-year-old
Key exclusion criteria
1. Patients who are bleeding
2. Patients who are pregnant or have the possibility of pregnancy
3. Patients who are seemed to be difficult to participate in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Fukuda |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL
03-3353-1211
kfukuda@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiko Nishiyama |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
Address
35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL
03-3353-1211
Homepage URL
ntakahiko914@gmail.com
Sponsor or person
Institute
Department of Cardiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mochida pharmaceutical company
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
Address
Tel
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
| 2014 | Year | 04 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015895
