Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Condition: Sleep Disordered Breathing; Sleep Apnea; Paroxysmal Atrial Fibrillation
MeSH terms: Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Atrial Fibrillation
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with
      prevalence expected to rise significantly the coming decades. The occurrence of AF is
      associated with significantly increased mortality as well as morbidity of which
      cerebrovascular accidents is the most important. Unfortunately treatment options remain
      limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential
      for toxicity and adverse events are recognized. Recent year's catheter ablation of AF
      continues to gain acceptance for symptomatic treatment, but recurrence rate are high with
      need for continuous medication. Thus there is a need to better understand what causes
      development and triggers episodes of AF as well to introduce new treatment options.
      Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore
      gained interest. Many patients with AF have chronic sleep apnea, and in the present study the
      investigators want to explore the interaction between SA and AF. The hypothesis of the
      present study is that SA may trigger AF and that treatment of SA will reduce the overall
      burden of AF as well as reduce the recurrence of AF after pulmonary vein ablation. To test
      the hypothesis the investigators will implant a Reveal device that continuously records the
      hearts rhythm of 100 patients with paroxysmal AF and concomitant SA. Initially the influence
      of SA on onset of AF will be examined, and the patients will then be randomized to treatment
      of SA or not and the influence on total AF burden recorded both before and after ablation.
    

Detailed description: 
      For the present project the investigators have established a research team from 2 different
      university hospitals. This team, including high ranked, internationally renowned scientist
      from both clinical and basic sciences, will make a framework for PhD candidates and will
      ensure the patient cohort. Patients with paroxysmal AF and SA will be examined with an
      extensive diagnostic battery including advanced cardiac imaging tools allowing a proper
      description of the heart. Then a Reveal that continuously monitor the rhythm of the heart
      will be inserted, allowing the influence of SA, physical activity, inflammatory parameters,
      and other external variables on total AF burden to be examined. The patients will then be
      randomized to treatment of SA with a CPAP or not, and the AF burden recorded 6 months before
      ablation and 6 months after.

      The present investigations carried out, are expected to results in better understanding of
      the interaction between AF and SA and may lay the scientific basis for better diagnostic and
      therapeutic approaches for patients with AF. In addition, given the advantage of continuous
      Reveal® recording of the patient's heart rhythm, the present study will examine possible
      triggers of AF such as activity level and inflammatory substances, and examine the role of
      structural abnormalities in the heart as assessed by echocardiography for the triggering of
      AF episodes. An overall aim is therefore a better phenotyping of the patient which could aid
      in a more person-specific treatment approach, with direct consequences both for the
      individual patient and for the society.
    

Intervention name(s): PAP (CPAP or ASV)
Intervention type(s): Device
Intervention description(s): Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; CPAP; Sleep apnea; Sleep disordered breathing