UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034697 |
|---|---|
| Receipt number | R000039530 |
| Scientific Title | Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure. |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2020/05/19 05:20:13 |
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Basic information
Public title
Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.
Acronym
Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.
Scientific Title
Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.
Scientific Title:Acronym
Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the relationship between 99mTc-MIBI and exercise capacity in patients with acute decompensated heart failure six months after a discharge and a discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigated the relationship between 99mTc-MIBI and exercise capacity in patients with acute decompensated heart failure six months after a discharge and a discharge.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
99mTc-MIBI and exercise tolerance
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
Improvement of acute signs and symptoms of heart failure.
Key exclusion criteria
Patient with severe aortic stenosis and mitral stenosis.
Patients under dialysis.
Patients with chronic lung disease.
Patients following stroke with neurological deficit.
Patients with severe liver cirrhosis and failure.
Patients with life-threatening malignancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
tkatou@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8431
Address
3-1-3 Hongo Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tkatou@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiovascular Medicine, Juntendo University School of Medicine
Address
3-1-3, Hongo, bunkyo-ku, Tokyo
Tel
0338133111
tkatou@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
| 2018 | Year | 11 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039530
