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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023423
Receipt No. R000026985
Scientific Title Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Date of disclosure of the study information 2016/08/01
Last modified on 2019/03/19

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Basic information
Public title Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Acronym Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Scientific Title Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Scientific Title:Acronym Effects of Eicosapentaenoil acid rich Fish Oil on Exercise economy in patients with Cardiovascular Diseases
Region
Japan

Condition
Condition Heart disorder
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In chronic heart failure patients and post PCI with acute coronary syndrome patients, we do a difference from the baseline of the oxygen intake of CPX three months later with an index after combined treatment initiation by exercise efficiency about the treatment that we combined placebo of experimental diet supplement A with for treatment and the basics treatment that we combined experimental diet supplement A(EPA) administration with for treatment (basic treatment) conventionally and test an advantage of the EPA combined treatment.
The safety weighs examinations for peripheral blood against the symptom of the patients for an index primarily.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes It is the same extreme(60% of the load at the maximum oxygen intake at CPX before beginning of dosage) oxygen intake at Cardiopulmonary Exercise Test(CPX) as of 12 weeks and a difference from the baseline after beginning of dosage
Key secondary outcomes An effective evaluation:It is the echocardiography evaluation as of at 12 weeks and 24 weeks, a fluidity of blood evaluation, drawing blood (CBC, lipid-based system, hsCRP, EPA/AA), quality of life questionary survey, an oxidative stress degree by the d-ROMs test after beginning of dosage.
It is the same extreme oxygen intake at CPX as of 24 weeks and a difference from the baseline after beginning of dosage
Safety assessment:Adverse event (bleeding tendency in particular, examination for peripheral blood (oligochromemia, leukopenia, thrombocytopenia, incidence) of high TG blood disease)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 EPA 900mg/day
Interventions/Control_2 placebo
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
41 years-old <
Age-upper limit
81 years-old >
Gender Male and Female
Key inclusion criteria 1)Less than LVEF40% or BNP 80pg/ml more
2)chronic heart failure patients or poat PCI with acute coronary syndrome patients
Key exclusion criteria 1)Recent cerebrovascular event within 3 months
2)Acute heart failure
3)Less than eGFR30
4)NOAC or Warfarin
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Yasu
Organization Dokkyo Medical University Nikko Medical Center
Division name Department of Cardiovascular medicine and Nephrology
Zip code 321-2593
Address 632 Takatoku, Nikko City, Tochigi
TEL 0288-76-1515
Email kawaatsu@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Niijima
Organization Dokkyo Medical University Nikko Medical Center
Division name Clinical Research Support Center
Zip code 321-2593
Address 632 Takatoku, Nikko City, Tochigi
TEL 0288-76-1515
Homepage URL
Email aniijima@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Nikko Medical Center
Institute
Department

Funding Source
Organization Nippon Suisan Kaisha,Ltd
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 Dokkyo Medical University Nikko Medical Center Clinical Research Support Center
Address 632 Takatoku, Nikko City, Tochigi
Tel 0288-76-1515
Email amiijima@dokkyomed.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
2016 Year 08 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 40
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
2016 Year 06 Month 20 Day
Date of IRB
2016 Year 05 Month 13 Day
Anticipated trial start date
2016 Year 07 Month 13 Day
Last follow-up date
2019 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 01 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026985

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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