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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034697
Receipt No. R000039530
Official scientific title of the study 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 2018/10/30

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Basic information
Official scientific title of the study Evaluation of mitochondrial function by 99m Tc-MIBI in patients with heart failure.
Title of the study (Brief title) 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 Takao Kato
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Address 3-1-3 Hongo Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email tkatou@juntendo.ac.jp

Public contact
Name of contact person Takao Kato
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Address 3-1-3 Hongo Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email tkatou@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039530

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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