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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027201
Receipt No. R000031169
Scientific Title Evaluation of renal function before and after catheter ablation of atrial fibrillation
Date of disclosure of the study information 2017/05/01
Last modified on 2019/05/03

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Basic information
Public title Evaluation of renal function before and after catheter ablation of atrial fibrillation
Acronym Evaluation of renal function before and after catheter ablation of atrial fibrillation
Scientific Title Evaluation of renal function before and after catheter ablation of atrial fibrillation
Scientific Title:Acronym Evaluation of renal function before and after catheter ablation of atrial fibrillation
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate renal function before and after catheter ablation of atrial fibrillation
Basic objectives2 Others
Basic objectives -Others To evaluate the marker of renal failure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes renal function (eGFR etc) before and after 1 to 6 months
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria patients who will undergo AF ablation
Key exclusion criteria hemodialysis
proteinuria >=1g/day
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shigeto
Middle name
Last name Naito
Organization Gunma Prefectural Cardiovascular Center
Division name Division of Cardiology
Zip code 371-0004
Address 3-12 Kameizumi-machi, Maebashi City, Gunma
TEL 027-269-7455
Email shigeto@tohgoku.or.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Take
Organization Gunma Prefectural Cardiovascular Center
Division name Division of Cardiology
Zip code 371-0004
Address 3-12 Kameizumi-machi, Maebashi City, Gunma
TEL 027-269-7455
Homepage URL
Email take-6@umin.ac.jp

Sponsor
Institute Gunma Prefectural Cardiovascular Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor The Sakakibara Heart Institute of Okayama
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gunma Prefectural Cardiovascular Center
Address 3-12 Kameizumi-machi, Maebashi City, Gunma
Tel 027-269-7455
Email take-6@umin.ac.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 群馬県立心臓血管センター(群馬県)
心臓病センター榊原病院(岡山県)

Other administrative information
Date of disclosure of the study information
2017 Year 05 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 20 Day
Date of IRB
2017 Year 04 Month 20 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate renal function,
the biomarker of renal failure is measured 3 times before and after catheter ablation(1-6months).

Management information
Registered date
2017 Year 04 Month 30 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031169

Research Plan
Registered date File name
2017/04/30 臨床研究計画書 微量アルブミン.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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