UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Registry of Atrial fibrillation in chronic Kidney disease Under hEmodialysis from Niigata
Title of the study (Brief title)	RAKUEN study
Region	Japan

Condition
Condition	Atrial Fibrillation End-stage renal disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigated the clinical features of AF patients undergoing hemodialysis.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	All-cause death,36 months
Key secondary outcomes	Major bleeding, Ischemic stroke

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients undergoing maintanance hemodialysis
Key exclusion criteria	non-dialysis patients
Target sample size	450

Research contact person
Name of lead principal investigator	Wataru Mitsuma
Organization	Shinrakuen hospital
Division name	Division of Cardiology
Address	3-3-11 Shindoriminami nisiku Niigata city
TEL	025-260-8200
Email	mwataru@hotmail.com

Public contact
Name of contact person	Wataru Mitsuma
Organization	Shinrakuen hospital
Division name	Division of Cardiology
Address	3-3-11 Shindoriminami nisiku Niigata city
TEL	025-260-8200
Homepage URL
Email	mwataru@hotmail.com

Sponsor
Institute	Shinrakuen hospital
Institute
Department

Funding Source
Organization	Shinrakuen hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	信楽園病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 29 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 06 Month 01 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The RAKUEN (Registry of Atrial fibrillation in chronic Kidney disease Under hEmodialysis from Niigata) study was a single-center, retrospective observational study, and the study protocol was reviewed and accepted by the local ethics committee of Shinrakuen Hospital (H26009).

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2017 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030701