UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014088 |
|---|---|
| Receipt number | R000016402 |
| Scientific Title | Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction. |
| Date of disclosure of the study information | 2014/05/27 |
| Last modified on | 2020/09/12 13:41:51 |
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Basic information
Public title
Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.
Acronym
Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.
Scientific Title
Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.
Scientific Title:Acronym
Effect of astaxanthin administration for heart failure patients with left ventricular systolic dysfunction.
Region
| Japan |
Condition
Condition
Heart failure due to left ventricular systolic dysfunction
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether three month administration of astaxanthin can induce 1) reductions of oxidative stress marker levels; 2) improvements of echocardiographic parameters for left ventricular functions; 3) reduction of plasma B-type natriuretic peptide level; 4) improvements of exercise tolerance; and 5) improvements of quality-of-life.
To assess whether there are correlation between changes in those parameters and increase in plasma level of astaxanthin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Changes in oxidative stress markers; 2) Changes in echocardiographic parameters; 3) Change in plasma B-type natriuretic peptide level; 4) Change in exercise tolerance; and 5) Changes in quality-of-life.
Key secondary outcomes
Correlations between primary outcomes and increase in plasma level of astaxanthin.
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
| Food |
Interventions/Control_1
Administration of astaxathin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) left ventricular ejection fraction <50%
2) NYHA functional class >= II
3) Ability to answer questionnaires by themselves
Key exclusion criteria
1) Patients with organic valvular heart disease
2) Smokers
3) Patients under dialysis
4) Patients with chronic lung diseases
5) Patients with chronic inflammatory diseases
6) Patients with neoplasms
7) Patients who can not walk alone
8) Patients who were considered as ineligible by attending physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University
Division name
Department of Cardiology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University
Division name
Department of Cardiology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tkasai@juntendo.ac.jp
Sponsor or person
Institute
Department of Cardiology, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
AstaReal Co., 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
aa
Address
aa
Tel
aa
aa@juntendo.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
| 2014 | Year | 05 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016402
