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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032188
Receipt No. R000036716
Scientific Title Short-term effect of positive airway pressure therapy in patients with atrial fibrillation and sleep-disordered breathing
Date of disclosure of the study information 2018/04/11
Last modified on 2018/04/10

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Basic information
Public title Short-term effect of positive airway pressure therapy in patients with atrial fibrillation and sleep-disordered breathing
Acronym Short-term effect of positive airway pressure therapy in patients with atrial fibrillation and sleep-disordered breathing
Scientific Title Short-term effect of positive airway pressure therapy in patients with atrial fibrillation and sleep-disordered breathing
Scientific Title:Acronym Short-term effect of positive airway pressure therapy in patients with atrial fibrillation and sleep-disordered breathing
Region
Japan

Condition
Condition Atrial fibrillation, heart failure, sleep disordered breathing
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether alleviation of sleep disordered breathing by positive airway pressure therapy can improve LV diastolic dysfunction and suppress sympathetic nerve activation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in E/e' by echocardiogram during 6 months and change in the H/M ratio and the wash out rate of 123I-MIBG during 6 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention group with positive airway pressure therapy (Continuous positive pressure therapy: CPAP and Adaptive servo ventilation: ASV) for 6 months
Interventions/Control_2 Control group with OMT (optimal medical therapy) for 6 months
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 1) Patients with AF (paroxysmal, persistent, and permanent)
2) Moderate to severe SDB (AHI is greater than or equal to 15 by home polygraphy test)
3) LV diastolic dysfunction (E/e' is greater than or equal to 15 by tissue Doppler echocardiogram)
Key exclusion criteria 1) LV systolic dysfunction (LV ejection fraction is less than or equal to 45% on echocardiogram)
2) Severe organic valvular diseases
3) Patients who have acute myocardial infarction, ICD or CRT device implantation, cardiac surgery including PCI and transcatheter aortic valve intervention during the 3 months preceding randomization.
4) Patients who have a possibility for pacemaker, ICD or CRT device implantation or cardiac or non-cardiac surgery including percutaneous coronary intervention, transcatheter aortic valve intervention in 3 months
5) Life-threatening diseases (uncured malignancy, severe chronic pulmonary diseases with oxygen inhalation or specific medication, and end stage renal disease with dialysis)
6) Patients who have already been initiated into PAP therapy
7) Pregnancy
Target sample size 60

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
2018 Year 04 Month 11 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
2018 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 04 Month 10 Day
Last modified on
2018 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036716

Research Plan
Registered date File name
2018/04/10 2.研究計画書 AF介入 松本v4.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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