UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017867 |
|---|---|
| Receipt number | R000020699 |
| Scientific Title | Consideration of cardiac function improvement effect of Omega-3 fatty acids(EPA +DHA) |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2015/06/10 20:11:34 |
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Basic information
Public title
Consideration of cardiac function improvement effect of Omega-3 fatty acids(EPA +DHA)
Acronym
Consideration of cardiac function improvement effect of Omega-3 fatty acids(EPA +DHA)
Scientific Title
Consideration of cardiac function improvement effect of Omega-3 fatty acids(EPA +DHA)
Scientific Title:Acronym
Consideration of cardiac function improvement effect of Omega-3 fatty acids(EPA +DHA)
Region
| Japan |
Condition
Condition
Chronic heart failure patient with dyslipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For chronic heart failure patients which merge dyslipidemia, consider a cardiac function improving effect by administering an Omega-3 fatty acids
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
LVEF, E/e', NTproBNP at 0, 6months after starting of treatment
Key secondary outcomes
TG,High sensitivity CRP, Quadrant blood fatty acid(EPA/AA)
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
Omega-3 fatty acid administration
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
1.Chronic heart failure of LVEF >=40% of non-ischemic cardiomyopathy
2.EPA/AA ratio is less than 0.5 of dyslipidemia
3.Patient who is competent to understand the aim of this study and agree on it
Key exclusion criteria
1. Patients who are bleeding
2. Past medical history of hypersensitivity 3. Judged as ineligible by physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Konomi Sakata |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
86-20-2 Shinkawa Mitaka Tokyo 181-8611 JAPAN
TEL
0422-47-5511
sakata@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Konomi Sakata |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
6-20-2 Shinkawa Mitaka Tokyo 181-8611 JAPAN
TEL
0422-47-5511
Homepage URL
sakata@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine, Second department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University School of Medicine, Second department of Internal Medicine
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
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
| 2015 | Year | 07 | Month | 01 | 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
| 2015 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020699
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
