Adaptive Servo-Ventilation and Central Apnea Associated with Systolic Heart Failure

Abstract

In individuals with symptomatic congestive heart failure (left ventricular ejection fraction ≤ 45%) and predominately central sleep apnea, does treatment of the sleep apnea with adaptive servo-ventilation (ASV), in addition to guideline based medical treatment change time to first event (composite of first event of death from any cause, lifesaving cardiovascular intervention [cardiac transplantation, implantation of a ventricular assist device, resuscitation after sudden cardiac arrest, or appropriate lifesaving shock], or unplanned hospitalization for worsening heart failure)? Methods DesignMulti-center, randomized, controlled trial; clinicaltrials.gov identifier: NCT00733343. AllocationRandomization was conducted by a centralized computer system. Allocation was stratified by country. The randomization sequence was concealed. BlindingThe investigators and participants were not blinded to study arm assignment. The primary outcome measurements were blinded. Follow-up periodThis was an event driven analysis. Participants were recruited over a period of 60 months with a total of 2-year follow-up until the target 651 observed events was reached. SettingPatients were recruited from each investigator's network of sleep and cardiology practices.