UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010770
Receipt number R000012428
Scientific Title Effects of Artrio-Venous fistula on the Circadian BP Rhythm
Date of disclosure of the study information 2013/05/21
Last modified on 2015/09/22 09:18:15

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Basic information

Public title

Effects of Artrio-Venous fistula on the Circadian BP Rhythm

Acronym

AVF & BP rhythm

Scientific Title

Effects of Artrio-Venous fistula on the Circadian BP Rhythm

Scientific Title:Acronym

AVF & BP rhythm

Region

Japan


Condition

Condition

Chronic Kidney Disease (CKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the arterio-venous fistula (AVF) can alter the circadian blood pressure rhythm in relation to change in the systemic volume overload

Basic objectives2

Others

Basic objectives -Others

burden on the systemic circulation with AVF

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

cadiac output,circadian BP rhythm, and urinary sodium excretion

Key secondary outcomes

1) heart rate variability (non-Gaussianity INDEX, , SDNN, VLF, HF, LF/HF, Alfa1, DC, HRT, HRVTI)
2) catecholamine
3) PRA, PAC, AI, AII, Urinary AGT
4) hANP, BNP
5) ADH, free water clearance


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Placement of AVF before the initiation of dialysis therapy

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

1) Need for the placement of AVF before the initiation of dialysis therapy
2) Confirmation of informed consent

Key exclusion criteria

1) Change in the antihypertensive medication one month before enrollment
2) Vasopressin antagonists
3) Endocrine hypertension
4) Accelerated o r malignant hypertension (progressive renal dysfunction with diastolic BP of >120-130 mmHg
5) Nephrotic syndrome (serum albumin <2.5 g/dl)
6) Serious conditions with congestive heart failure, coronary diseases, arrhythmia or systemic diseases
7) Implantation of a pacemaker
8) During pregnancy
9) Any reason for ineligibility suggested by the attending doctor (usage of beta-blockers)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michio FUKUDA

Organization

Nagoya City University Hospital

Division name

Division of Nephrology

Zip code


Address

1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan

TEL

81-52-853-8221

Email

m-fukuda@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Michio FUKUDA

Organization

Nagoya City University Hospital

Division name

Division of Nephrology

Zip code


Address

1 Kawasumi, Mizuho-ku, Nagoya 467-8601, Japan

TEL

81-52-853-8221

Homepage URL

http://www.med.nagoya-cu.ac.jp/cr.dir/

Email

m-fukuda@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Department of Cardio-Renal Medicine and Hypertension, Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

名古屋市立大学病院


Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 21 Day


Related information

URL releasing protocol

http://www.med.nagoya-cu.ac.jp/cr.dir/

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Interim results were Reported in the JSN2013.
Twelve subjects were enrolled.
under reporting the dissertation

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

2013 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 10 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2016 Year 01 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 21 Day

Last modified on

2015 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012428


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name