UMIN-CTR Clinical Trial

Basic information
Public title	Effects of eicosapentaenoic acid on left ventricular function in patients with nonischemic cardiomyopathy
Acronym	Effects of eicosapentaenoic acid to nonischemic cardiomyopathy
Scientific Title	Effects of eicosapentaenoic acid on left ventricular function in patients with nonischemic cardiomyopathy
Scientific Title:Acronym	Effects of eicosapentaenoic acid to nonischemic cardiomyopathy
Region	Japan

Condition
Condition	chronic heart failure due to nonischemic cardiomyopathy
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effect of eicosapentaenoic acid in patients with chronic heart failure due to nonischemic cardiomyopathy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	physical sign biomarker left ventricular function
Key secondary outcomes

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	Dose:EPA 1800mg Duration:6 months
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who agree a participation in this study by a document 2. Patients with chronic heart failure due to nonischemic cardiomyopathy 3. Patients who are more than 20-year-old and under 80-year-old
Key exclusion criteria	1. Patients who are bleeding 2. Patients who are pregnant or have the possibility of pregnancy 3. Patients who are seemed to be difficult to participate in this study
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Keiichi Fukuda
Organization	Keio University School of Medicine
Division name	Cardiology
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL	03-3353-1211
Email	kfukuda@a2.keio.jp

Public contact
1st name of contact person	1st name Middle name Last name Takahiko Nishiyama
Organization	Keio University School of Medicine
Division name	Cardiology
Zip code
Address	35 Shinanomachi Shinjuku-ku Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	ntakahiko914@gmail.com

Sponsor
Institute	Department of Cardiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Mochida pharmaceutical company
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
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	2014 Year 04 Month 02 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	Terminated
Date of protocol fixation	2012 Year 02 Month 27 Day
Date of IRB	2012 Year 02 Month 27 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 02 Day
Last modified on	2019 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015895