UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031056
Receipt number R000035464
Scientific Title Evaluation of kidney injury associated with atrial fibrillation (KIDI-AF)
Date of disclosure of the study information 2018/03/01
Last modified on 2020/02/07 17:51:26

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Basic information

Public title

Evaluation of kidney injury associated with atrial fibrillation (KIDI-AF)

Acronym

Atrial fibrillation and renal function

Scientific Title

Evaluation of kidney injury associated with atrial fibrillation (KIDI-AF)

Scientific Title:Acronym

Atrial fibrillation and renal function

Region

Japan


Condition

Condition

Persistent atrial fibrillation, Chronic kidney disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the mechanisms of renal impairment induced by atrial fibrillation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Serum Creatinine and eGFR and renal perfusion flow on 12 months after the catheter ablation procedure.

Key secondary outcomes

Laboratory data, electrocardiography, ultrasonography, and other data on 12 months after the catheter ablation procedure.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with chronic kidney disease (i.e. eGFR < 60ml/min/1.73cm2 and/or proteinuria) who underwent catheter ablation for persistent atrial fibrillation between February 1, 2018 to January 31, 2021 in Kanazawa Medical Center.

Key exclusion criteria

Patients with hemodialysis. Patients who cannot make informed consent.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Sakagami

Organization

National Hospital Organization, Kanazawa Medical Center

Division name

Department of Cardiovascular medicine

Zip code

9208650

Address

1-1 shimo-ishibiki-machi, Kanazawa

TEL

076-262-4161

Email

sakagami.satoru.wx@mail.hosp.go.jp


Public contact

Name of contact person

1st name Yoichiro
Middle name
Last name Nakagawa

Organization

National Hospital Organization, Kanazawa Medical Center

Division name

Department of Cardiovascular medicine

Zip code

9208650

Address

1-1 shimo-ishibiki-machi, Kanazawa

TEL

076-262-4161

Homepage URL


Email

apricotken_megu@yahoo.co.jp


Sponsor or person

Institute

Department of Cardiovascular medicine, National Hospital Organization, Kanazawa Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee, Kanazawa Medical Center

Address

1-1 Shimo-ishibiki, Kanazawa, Ishikawa, Japan

Tel

076-262-4161

Email

302iy01@hosp.go.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

独立行政法人国立病院機構金沢医療センター(石川県)


Other administrative information

Date of disclosure of the study information

2018 Year 03 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

Open public recruiting

Date of protocol fixation

2017 Year 12 Month 25 Day

Date of IRB

2018 Year 01 Month 16 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We investigate the parameters of cardiac and renal functions before and after catheter ablation of persistent atrial fibrillation.


Management information

Registered date

2018 Year 01 Month 30 Day

Last modified on

2020 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035464


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name