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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017867
Receipt No. 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

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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
Email 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
Email sakata@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University School of Medicine, Second department of Internal Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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