UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011468 |
|---|---|
| Receipt number | R000013316 |
| Scientific Title | Effects of LOTRIGA in chronic heart failure patients with hyperlipidemia:a prospective randomized,open-label,parallel group comparison study |
| Date of disclosure of the study information | 2013/08/15 |
| Last modified on | 2017/02/15 19:34:11 |
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Basic information
Public title
Effects of LOTRIGA in chronic heart failure patients with hyperlipidemia:a prospective randomized,open-label,parallel group comparison study
Acronym
Effects of LOTRIGA in chronic heart failure patients with hyperlipidemia(EPA/DHA study)
Scientific Title
Effects of LOTRIGA in chronic heart failure patients with hyperlipidemia:a prospective randomized,open-label,parallel group comparison study
Scientific Title:Acronym
Effects of LOTRIGA in chronic heart failure patients with hyperlipidemia(EPA/DHA study)
Region
| Japan |
Condition
Condition
chronic heart failure with hyperlipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate effects of n-3 polyunsaturated fatty acids LOTRIGA on left ventricular systolic function in chronic heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
a rate of change of LVEF after dosage from baseline to 12-months follow-up
Key secondary outcomes
a rate of change of LVEF after dosage from baseline to 6-months follow-up
major adverse cardiac event(cardiovascular death,non-fatal MI,UAP,hospitalization for heart failure,stroke,other cardiovascular events)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
LOTRIGA group
Interventions/Control_2
non-LOTRIGA group
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.LVEF<50% even though standard medical treatments for heart failure
2.stable out patient for more than 3 months
3.patients who are not enrolled in other clinical trial
4.written consent
Key exclusion criteria
1.patients who are planned PCI or CABG
2.patients who have myocardial ischemia
3.unstable patient due to non-cardiac disease
4.pregnant woman
5.patients who are judged to be inappropriate to this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Amano |
Organization
Aichi Medical University
Division name
Department of Cardiology
Zip code
Address
1-1 Yazakokarimata Nagakute Aichi
TEL
0561-62-3311
amanot@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Nakano |
Organization
Aichi Medical University
Division name
Department of Cardiology
Zip code
Address
Yazakokarimata1-1, Nagakute city, Aichi
TEL
0561-62-3311
Homepage URL
nakanoy@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University,Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
愛知医科大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | 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
| 2013 | Year | 08 | Month | 12 | Day |
Last modified on
| 2017 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013316
