UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020203 |
|---|---|
| Receipt number | R000022720 |
| Scientific Title | Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2018/12/17 09:31:25 |
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Basic information
Public title
Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc
Acronym
Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc
Scientific Title
Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc
Scientific Title:Acronym
Study of a heart failure treatment using a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement of symptoms and QOL with a combination drug consisting of reduced coenzyme Q10, astaxanthin, citrulline, and zinc in patients with intractable heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.BNP
2.QOL (6-min walk test, EQ-5D)
3.LVEF by echocardiography
Key secondary outcomes
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
coenzyme Q10
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
Outpatients with chronic heart failure (including DCM and OMI) who meet the following conditions:
(1) LVEF < 40%
(2) BNP level > 200 pg/mL
(3) Plasma coenzyme Q10 concentrations < 950 ng/mL
(4) Age >= 20 years
(5) Patients who adequately understand the objectives and details of this study, and give a written informed consent
Key exclusion criteria
(1)Patients who meet the following criteria are excluded: those who have not completely recovered from a malignancy; with severe infection; suspected of having a pulmonary disease (including COPD) on a chest radiogram; who are on dialysis; and others who are found unacceptable at the discretion of the physician
(2)Patients who have taken drugs or supplements including coenzyme Q10, astaxanthin, and citrulline within the last 2 months
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Sakurada |
Organization
Tokorozawa Heart Center, Medical Corporation Ouyuukai
Division name
Cardiovascular desease center
Zip code
Address
2-61-11, Kamiarai Tokorozawa Saitama 359-1142
TEL
04-2940-8611
masami-saku@mh.point.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | satomi kohata |
Organization
A2 Healthcare Corporation
Division name
Clinical Research Department
Zip code
Address
Sumitomo Fudosan Bldg,1-4-1,Koishikawa,Bunkyo-ku,Tokyo
TEL
03-3830-1075
Homepage URL
kohata-s@a2healthcare.com
Sponsor or person
Institute
Tokorozawa Heart Center, Medical Corporation Ouyuukai
Institute
Department
Personal name
Funding Source
Organization
Your Health Care 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
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
1）所沢ハートセンター
2）三重ハートセンター
3）草津ハートセンター
4）豊橋ハートセンター
5）京都桂病院 心臓血管センター
6）帝京大学医学部附属病院 循環器内科
7）上尾中央総合病院 心臓血管センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
