UMIN-CTR Clinical Trial

Basic information
Public title	Significant Correlation between Renal 123I-Metaiodobenzylguanidine Scintigraphy and Muscle Sympathetic Nerve Activity in Patients with Heart Failure with Reduced Ejection Fraction
Acronym	Study of renal MIBG in HFrEF patients
Scientific Title	Significant Correlation between Renal 123I-Metaiodobenzylguanidine Scintigraphy and Muscle Sympathetic Nerve Activity in Patients with Heart Failure with Reduced Ejection Fraction
Scientific Title:Acronym	Study of renal MIBG in HFrEF patients
Region	Japan

Condition
Condition	HFrEF
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we hypothesized that HFrEF patients whose sympathetic nerves and humoral factor interaction are accelerated by pressure overloading, the dynamics of 123I is more likely to be observed. We compared renal MIBG and sympathetic nerve parameters and heart function indicators and examined how renal MIBG is related to cardiac function and circulatory dynamics.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	MIBG,MSNA
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	HFrEF was defined according to the guidelines of the Japanese Circulation Society 10 for diagnosis and treatment of acute and chronic heart failure as left ventricular ejection fraction less than 40%.
Key exclusion criteria	Patients with an estimated glomerular filtration rate of <50 ml/min/1.73 m2, morphological kidney abnormality, renal vascular stenosis, advanced lung disease, mental illness, or acute cardiovascular disease were excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Okabe
Organization	Kanazawa University
Division name	cardiology
Zip code	920-0934
Address	Kanazawa city Takaramachi
TEL	09056828475
Email	yosi3305@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Okabe
Organization	Kanazawa University
Division name	cardiology
Zip code	920-0934
Address	Kanazawa city Takaramachi
TEL	0770223611
Homepage URL
Email	yosi3305@yahoo.co.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Kanazawa University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
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Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanazawa university hospital
Address	Kanazawa city Takaramachi
Tel	09056828475
Email	yosi3305@yahoo.co.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 09 Month 03 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Results Delayed
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 01 Day
Date of IRB	2014 Year 08 Month 03 Day
Anticipated trial start date	2014 Year 08 Month 05 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	I have finished observing 20 cases

Management information
Registered date	2018 Year 09 Month 03 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038770

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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