UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029327 |
|---|---|
| Receipt number | 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 | 2024/10/03 22:16:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University Graduate School of Medicine
Division name
Cardiovascular Respiratory Sleep Medicine
Zip code
113-0033
Address
3-3-1-303 Hongo, Bunkyo-Ku, Tokyo
TEL
03-6873-2869
kasai-t@mx6.nisiq.net
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University Graduate School of Medicine
Division name
Cardiovascular Respiratory Sleep Medicine
Zip code
113-0033
Address
3-3-1-303 Hongo, Bunkyo-Ku, Tokyo
TEL
03-6873-2869
Homepage URL
kasai-t@mx6.nisiq.net
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Cardiovascular Respiratory Sleep Medicine
Institute
Department
Personal name
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
Juntendo University Hospital Medical Research Ethics Committee
Address
3-1-3 Hongo, Bunkyo-Ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.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
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
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033520
