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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
The CSA group will undergo 2 sleep evaluation on two consecutive nights, during which the device will be programmed according to the randomization scheme (one night CRT, DDD/45 and the other CRT, DDD/15 bpm over mean nocturnal heart rate). The mean nocturnal heart rate over the last week is derived from the device memory.
Medizinische Klinik und Poliklinik II Universitätsklinikum, University of Bonn
Bonn, Germany
Georg-August-Universität, Department of Cardiology and Pneumology
Göttingen, Germany
AHI
To demonstrate that a single night of overdrive pacing applied after 12 weeks of cardiac resynchronization therapy in comparison to cardiac resynchronization alone will improve sleep apnea as measured by Apnea- hypopnea- index (AHI)
Time frame: 12 weeks
NYHA class
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on NYHA
Time frame: 12 weeks
Echocardiographic parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on LVEF
Time frame: 12 weeks
Neurohormonal parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on neurohormonal marker NT pro-BNP
Time frame: 12 weeks
Clinical parameter
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on the clinical parameter VO2max
Time frame: 12 weeks
Quality of Life
To evaluate the effects of nocturnal overdrive pacing applied after 12 weeks of CRT vs. CRT alone on Quality of life
Time frame: 12 weeks
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