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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029327
Receipt No. R000033520
Scientific Title Prevalence and prognostic impact of sleep disordered breathing (SDB) in patients with atrial fibrillation (AF)
Date of disclosure of the study information 2017/09/28
Last modified on 2018/10/10

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Basic information
Public title Prevalence and prognostic impact of sleep disordered breathing (SDB) in patients with atrial fibrillation (AF)
Acronym RAFFINE-SAS
Scientific Title Prevalence and prognostic impact of sleep disordered breathing (SDB) in patients with atrial fibrillation (AF)
Scientific Title:Acronym RAFFINE-SAS
Region
Japan

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

Objectives
Narrative objectives1 To investigate the prevalence and prognostic impact of sleep disordered breathing in patients with atrial fibrillation
Basic objectives2 Others
Basic objectives -Others To investigate the prognosis of patients with atrial fibrillation and sleep disordered breathing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All cause death
Hospitalization due to stroke and heart failure
Key secondary outcomes

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 polygraphy for sleep disordered breathing
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 Atrial fibrillation (paroxysmal, persistent, permanent)
Key exclusion criteria Left ventricular systolic dysfunction
Primary valvular diseasee
Malignancy
COPD
hemodialysis
Positive airway pressure therapy
Pregnancy
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Kasai
Organization Juntendo University Graduate School of Medicine
Division name Cardiovascular Respiratory Sleep Medicine
Zip code
Address 2-1-1 Hongo, Buryo-Ku, Tokyo
TEL 03-3813-3111
Email kasai-t@mx6.nisiq.net

Public contact
Name of contact person
1st name
Middle name
Last name Takatoshi Kasai
Organization Juntendo University Graduate School of Medicine
Division name Cardiovascular Respiratory Sleep Medicine
Zip code
Address 2-1-1 Hongo, Buryo-Ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kasai-t@mx6.nisiq.net

Sponsor
Institute Juntendo University Graduate School of Medicine
Cardiovascular Respiratory Sleep Medicine
Institute
Department

Funding Source
Organization Resmed Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 28 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033520

Research Plan
Registered date File name
2018/04/10 2.研究計画書(順天堂雛形)ResMed AF ver3.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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