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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033998
Receipt No. R000038770
Scientific Title Significant Correlation between Renal 123I-Metaiodobenzylguanidine Scintigraphy and Muscle Sympathetic Nerve Activity in Patients with Heart Failure with Reduced Ejection Fraction
Date of disclosure of the study information 2018/09/03
Last modified on 2018/09/03

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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
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
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
Middle name
Last name Okabe Yoshitaka
Organization Kanazawa University
Division name cardiology
Zip code
Address Kanazawa city Takaramachi
TEL 09056828475
Email yosi3305@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Okabe Yoshitaka
Organization Kanazawa University
Division name cardiology
Zip code
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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 09 Month 03 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
Registered date File name


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