NCT00551499

Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure
• Central Sleep Apnea

Interventions

Type	Name	Description
DEVICE	CRT + AOP	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.

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2007-10-31
• Last updated: 2025-07-03

Locations

2 sites across 1 country: Germany