Atrial fibrillation, heart failure, sleep disordered breathing
Conditions
Interventions
Intervention group with positive airway pressure therapy (Continuous positive pressure therapy: CPAP and Adaptive servo ventilation: ASV) for 6 months
Control group with OMT (optimal medical therapy)
Sponsors
Juntendo University Graduate School of Medicine Cardiovascular Respiratory Sleep Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakatoshi Kasai
Juntendo University Graduate School of Medicine Cardiovascular Respiratory Sleep Medicine
Outcome results
None listed