Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients
 with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of
 overdrive pacing. Secondary objectives are to evaluate the effects of a single night of
 overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping
 events, and neurohormonal markers. An additional secondary objective of the study is to
 compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without
 concomitant CSA.
Sleep apnea is a common and often undiagnosed disorder associated with substantial
 cardiovascular morbidity and mortality. In recent years studies have been published
 presenting the relationship between heart failure (HF) and central sleep apnea (CSA). CSA
 associated with Cheyne-Stokes respiration is a form of periodic breathing in which central
 apneas and hypopnea alternate with periods of hyperventilation, characterized by a regular
 crescendo-decrescendo oscillation of tidal volume, which is thought to be caused by
 dysfunction of central respiratory control. Unlike, obstructive sleep apnea (OSA), CSA likely
 arises as a consequence of HF.Since 2002, several results have reported on the benefit of
 atrial overdrive (AOP) pacing in patients suffering from sleep apnea. These results could not
 be confirmed for obstructive sleep apnea in several subsequent studies. Cardiac
 resynchronization therapy (CRT) has been proposed as another potential therapeutic pacing
 approach for CSA by two recently published investigations.The combined therapeutic impact of
 AOP and CRT (CRT+AOP) so far has not been investigated.We aimed to evaluate the effect of CRT
 alone and CRT+AOP on CSA in patients with CHF.
Inclusion Criteria:

 -  Patients with documented clinical history of symptomatic but stable congestive heart
 failure, NYHA III or NYHA IV, of at least six weeks duration.

 -  Patient has an indication for a CRT device, or patients with previous pacemaker
 indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT
 device

 -  Patient is scheduled for the implantation of a CRT device

 -  Patient is over 18 years of age

 -  Patient provides Informed Consent

 Exclusion Criteria:

 -  Inability to complete overnight sleep study as specified by the protocol

 -  Myocardial infarction or coronary revascularization procedure within 2 calendar months
 prior to enrollment

 -  Planned or strong likelihood of cardiac surgery within 4 months following enrollment

 -  A spirometric confirmation of obstructive lung disease

 -  Evidence of obstructive sleep apnea at baseline polysomnography

 -  Body mass index >30 kg/m²

 -  Pregnant women