UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033998
Receipt number 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 2020/03/05 09:22:33

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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 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 or person

Institute

Kanazawa University

Institute

Department

Personal name



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

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

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

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

Value
https://center6.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