UMIN-CTR Clinical Trial

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
Email	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
Email	tkatou@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039530