UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022564 |
|---|---|
| Receipt number | R000025531 |
| Scientific Title | Role of blood cell mitochondria in heart failure |
| Date of disclosure of the study information | 2016/06/02 |
| Last modified on | 2022/03/26 16:44:53 |
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Basic information
Public title
Role of blood cell mitochondria in heart failure
Acronym
BLOODMITO-HF
Scientific Title
Role of blood cell mitochondria in heart failure
Scientific Title:Acronym
BLOODMITO-HF
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the role of blood cell mitochondria in heart failure
Basic objectives2
Others
Basic objectives -Others
To test the hypothesis that mitochondrial defects in blood cells may contribute to pathogenesis and development of heart failure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mitochondrial respiratory capacity in blood cells
Key secondary outcomes
1)Mitochondrial oxidative stress originated from blood cells
2)Systemic inflammatory biomarkers
3)Systemic oxidative stress
4)Gene expression and protein synthesis regarding mitochondrial function, mitochondrial biogenesis, morphology, and inflammatory cytokines
5)Mitochondrial density in blood cells
6)Events (all-cause death, cardiac death, all-cause hospitalization, and hospitalization for worsening heart failure)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Heart failure patients who have a history of hospital admission or who are hospitalized for worsening of heart failure
Key exclusion criteria
1)Patients with active inflammation
2)Patients with malignant tumor
3)Patients who are receiving steroid or immunosuppressant
Target sample size
83
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Takashi |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo
TEL
011-706-6973
t-yokota@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo
TEL
011-706-6973
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Mochida Memorial Foundation for Medical and Pharmaceutical Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2016 | Year | 06 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)Study patients: Patients with heart failure and healthy subjects as controls
2)Target sample size: 83 (heart failure group n=55, control group n=28)
Management information
Registered date
| 2016 | Year | 06 | Month | 01 | Day |
Last modified on
| 2022 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025531
| 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 |
