UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023423
Receipt number 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 17:33:55

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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 or person

Institute

Dokkyo Medical University Nikko Medical Center

Institute

Department

Personal name



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

Value
https://center6.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