UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012604 |
|---|---|
| Receipt number | R000014738 |
| Scientific Title | Effect of the REduced form of COenzyme Q10 Supplementation on endothelial function in chronic heart failure |
| Date of disclosure of the study information | 2013/12/17 |
| Last modified on | 2019/07/02 13:18:30 |
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Basic information
Public title
Effect of the REduced form of COenzyme Q10 Supplementation on endothelial function in chronic heart failure
Acronym
RECOQS
Scientific Title
Effect of the REduced form of COenzyme Q10 Supplementation on endothelial function in chronic heart failure
Scientific Title:Acronym
RECOQS
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether ubiquinol improves endothelial function in chronic heart failure patients or not.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in endothelial function assessed by EndoPAT 2000 between before and after intervention.
Key secondary outcomes
Changes in functional capacity, left ventricular function, oxydative stress marker, inflammation marker, and COQ10 concentration in peripheral blood.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ubiquinol 200mg twice daily, 12 weeks, followed by placebo 12 weeks
Interventions/Control_2
Placebo 12 weeks, followed by Ubiquinol 200mg twice daily, 12 weeks
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic heart failure patients whose left ventricular ejection fraction are less than 40 %.
Key exclusion criteria
Malignancy, severe infection, severe trauma, hemodialysis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kimura |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
2320024
Address
4-57 Urafune-cho, Minami-ku, Yokohama
TEL
045-261-5656
c-kimura@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Konishi |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
2320024
Address
4-57 Urafune-cho, Minami-ku, Yokohama
TEL
045-261-5656
Homepage URL
m_koni@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Medical Center
Address
4-57 Urafune-cho, Minami-ku, Yokohama
Tel
045-261-5656
chihirou@yokohama-cu.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
| 2013 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 10 | 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
| 2013 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014738
