Influence of Sleep Apnea on Risk of Atrial Fibrillation
Source: ClinicalTrials.gov NCT02576587 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Paroxymal Atrial Fibrillation (PAF) |
150; 0 | 0.054 |
| SECONDARY Echocardiography Measures- Left Atrial Volume |
67; 72 | 0.16 |
| SECONDARY Echocardiographic Measures- LA Volume Index |
31; 30 | 0.088 |
| SECONDARY Echocardiographic Measures- LA Systolic Strain by A4C View |
36; 29 | 0.006 sig |
| SECONDARY Echocardiographic Measures- LA Systolic Strain by A2C View |
36; 37 | 0.59 |
| SECONDARY Vascular Measures- Pulse Wave Velocity |
9.5; 10.5 | 0.65 |
| SECONDARY Vascular Measures- Augmentation Index |
28.6; 26.9 | 0.65 |
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria for Cases:
PAF defined by recurrent episodes of AF, which self-terminate within a 7-day period (based upon AHA consensus statement 77)
Age 18-80 years
Individuals able to participate in > 2 overnight/daytime sleep and physiologic assessments over a 3 month period.
Inclusion Criteria for Controls:
Age 18 to 80 years
Individuals in normal sinus rhythm (NSR) with no current AF or history of AF
Individuals able to participate in an overnight/daytime sleep and physiologic assessment.
Exclusion Criteria
Exclusion Criteria for Cases:
PAF with rapid or uncontrolled rate (>120bpm)
Post-operative PAF
History of cardiac ablation or successful electro-cardioversion for PAF (ablation for other arrhythmias such as AVNRT and if PAF persists after cardioversion is acceptable )
Valvular stenosis, prosthesis or significant valvular insufficiency [i.e. those with moderate or greater severity of aortic stenosis (aortic valve area 20% regurgitant fraction) or moderate or greater severity mitral stenosis (mitral valve area 170/110), abdominal aneurysm >5.5 cm or >1 cm growth/year, uncontrolled diabetes mellitus (HbA1c>9.0), pulmonary hypertension, non-skin cancer diagnosis or treatment within the previous year, end stage renal and hepatic failure, immunodeficiencies (HIV, HCV), uncontrolled hypo- or hyperthyroidism)
Psychiatric disorders which are inadequately treated
Compromised competence
Alcohol abuse (currently drinks >5 alcoholic drinks/day)
Pregnancy
Inability to provide informed consent
Illicit drug use over last 6 months
Rate controlling anti-arrhythmic medication (Classes I-III and V) with no further clinical occurrence of PAF
Has a Pacemaker or Implantable cardioverter-defibrillator.
Rationale for criteria: The goal of this study is to include those patients with PAF that is not secondary to the post-operative period or valvular disease and without ablation as these processes would result in alteration of atrial physiology and preclude assessment of independent SDB effects on AF which is independent of these conditions. Patients with sleep disorders will be excluded as sleep disorders may influence arrhythmogenesis. Those on treatment for SDB will be excluded because treatment would preclude assessment of SDB pathophysiologic effects on atrial arrhythmogenesis. Those with unstable medical conditions or rapid or uncontrolled heart rate will be excluded due to safety reasons.
Note: Exclusion criteria for positive airway pressure (PAP) intervention: Central Apnea Index>5 noted on baseline examination sleep study or evidence of Cheyne Stokes Respirations/periodic breathing (cyclical crescendo and decrescendo change in breathing amplitude).
Exclusion Criteria for Controls:
Current or history of AF, otherwise the same exclusion criteria listed for cases.
Data sourced from ClinicalTrials.gov (NCT02576587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.