UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027248 |
|---|---|
| Receipt number | R000029847 |
| Scientific Title | Effects of Reduced Form of Coenzyme Q10 (ubiquinol) on Heart Failure and Arrhythmias |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/11/11 18:08:40 |
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Basic information
Public title
Effects of Reduced Form of Coenzyme Q10 (ubiquinol) on Heart Failure and Arrhythmias
Acronym
CoQ10-HF
Scientific Title
Effects of Reduced Form of Coenzyme Q10 (ubiquinol) on Heart Failure and Arrhythmias
Scientific Title:Acronym
CoQ10-HF
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate improving effects of reduced form of Coenzyme Q10 (ubiquinol) on congestive heart failure and arrhythmias of the patients with implantation of pacemaker or ICD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Heart filure indices (OptiVol or CorVue), arrhythmias of the implanted device before and 6months after ubiquinol/placebo
Key secondary outcomes
activity time recorded on the implanted device
Physical Activity Score
Nutrition (CONUT score, GNRI)
BNP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
placebo and conventional therapy
6 months
Interventions/Control_2
Add-on of reduced form Coenzyme Q10
100mg three times a day
6 months
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
patients of congestive heart failure (NYHA
II and above) with pacemaker or implantable cardioverter defibrillator implantation, including cardiac resynchronization therapy
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Satoaki |
| Middle name | |
| Last name | Matoba |
Organization
Kyoto Prefectral University of Medicine
Division name
Cardiovascular Medicine
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5511
matoba@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Shirayama |
Organization
Kyoto Prefectral University of Medicine
Division name
Cardiovascular Medicine
Zip code
602-8566
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5511
Homepage URL
sirayama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectral University of Medicine,
Division of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectral University of Medicine,
Division of Cardiovascular Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Clinical Research Review Board
Address
Kamawamachi-Hirokoji, kamigyo-ku, kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
10
Results
no results because of termination
Results date posted
| 2019 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029847
