UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000026985