Treatment of sleep apnea in patients with paroxysmal atrial fibrillation: design and rationale of a randomized controlled trial
Gunn Marit Traaen, Lars Aakerøy, Tove-Elizabeth Hunt, Britt Øverland, Erik Lyseggen, Pål Aukrust, Thor Ueland, Thomas Helle-Valle, Sigurd Steinshamn, Thor Edvardsen, Hasse Khiabani Zaré, Svend Aakhus, Harriet Akre, Ole- Gunnar Anfinsen, Jan Pål Loennechen & Lars Gullestad
Studien er publisert i Scandinavian Cardiovascular Journal
RATIONALE: Atrial fibrillation is
associated with increased mortality as well as morbidity. There is strong
evidence for an association between atrial fibrillation and sleep apnea. It is
not known whether treatment of sleep apnea with continuous positive airway
pressure (CPAP) will reduce the burden of atrial fibrillation.
OBJECTIVE: The Treatment of Sleep Apnea
in Patients with Paroxysmal Atrial Fibrillation study will investigate the
effects of CPAP in patients with paroxysmal atrial fibrillation and sleep
DESIGN: The trial has a dual center,
randomized, controlled, open-label, parallel design.
METHODS: Two centers will enroll a
total of 100 patients with both paroxysmal atrial fibrillation and sleep apnea
(apnea-hypopnea index [AHI] ≥ 15 events/h) who are scheduled for catheter
ablation. Patients will be randomized in a 1:1 ratio to CPAP or control group
(50 patients in each arm). The effects of CPAP treatment on atrial fibrillation
will be determined using an implanted loop recorder (Reveal LINQ™, Medtronic)
that detects all arrhythmia episodes. The primary endpoint is a reduction of
the total burden of atrial fibrillation in the intervention group, after 5
months' follow-up (preablation). Reduction in the arrhythmia recurrence rate
after ablation is the main secondary endpoint. All patients will be followed up
for 12 months after ablation.
CONCLUSION: This study is the first
randomized controlled trial that will provide data on the effects of CPAP
therapy in patients with paroxysmal atrial fibrillation and sleep apnea. The
results are expected to improve our understanding of the interaction between
paroxysmal atrial fibrillation and sleep apnea.