UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012603 |
|---|---|
| Receipt number | R000014737 |
| Scientific Title | Effect of Omega-3 polyunsaturated fatty acids in patients with heart failure and preserved ejection fraction |
| Date of disclosure of the study information | 2013/12/16 |
| Last modified on | 2013/12/16 23:20:19 |
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Basic information
Public title
Effect of Omega-3 polyunsaturated fatty acids in patients with heart failure and preserved ejection fraction
Acronym
Effect of Omega-3 polyunsaturated fatty acids in patients with heart failure and preserved ejection fraction
Scientific Title
Effect of Omega-3 polyunsaturated fatty acids in patients with heart failure and preserved ejection fraction
Scientific Title:Acronym
Effect of Omega-3 polyunsaturated fatty acids in patients with heart failure and preserved ejection fraction
Region
| Japan |
Condition
Condition
heart failure and preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the primary objective is to determine whether omega-3 polyunsaturated fatty acids improve diastolic function in patients with heart failure with preserved ejection fraction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diastolic function (E/e')on echocardiography
cardiac function on MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1800mg of EPA daily with 6 months of follow up
Interventions/Control_2
control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
symptomatic out patients had a EF more than 50%
and
E/e' more than 15 or(8<E/e'<15 and BNP>200)
and
hyperlipemia
Key exclusion criteria
reduced LVEF
accute coronary syndromes
severe valvular heart disease
neoplasms
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekuni Kirigaya |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
cardiovascular medicine
Zip code
Address
6-16-1, Tomiokahigashi, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0051, Japan
TEL
045(701)9581
ycum_51st_syougai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekuni Kirigaya |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
cardiovascular medicine
Zip code
Address
6-16-1, Tomiokahigashi, Kanazawa-ku Yokohama-shi, Kanagawa, 236-0051, Japan
TEL
045(701)9581
Homepage URL
ycum_51st_syougai@yahoo.co.jp
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | 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 | 12 | Month | 16 | Day |
Last modified on
| 2013 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014737
