UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032188 |
|---|---|
| Receipt number | 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 | 2019/10/14 10:27:18 |
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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
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
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
Address
Tel
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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036716
