CHEST® Resource Center

- Figure 36

Progress

FIG. 36:  This Figure shows the status of ADVENT-HF as of April 21, 2016.  To date, 366 patients have been randomized in the trial. Most patients have OSA (65%), which means that this cohort is representative of what we know about the epidemiology of sleep apnea and heart failure. 

Nightly usage of the ASV device to date is 1.1 hours longer than in SERVE-HF(4.8 hr/night vs 3.7 hr/night[15]), an important difference. 

The patients enrolled in ADVENT-HF are not as sick as those in SERVE-HF; 60% have NYHA Class II heart failure and only 22% NYHA class III, the reverse of the patients in SERVE-HF.[15] 

To date there have been 328 adjudicated serious adverse events (SAEs), which is close to the predicted number, and the DSMB has monitored the data twice since the results of SERVE-HF were announced.  They have found no safety concerns in either the OSA or the CSA patients, and they have recommended continuation with both the OSA and CSA patients per protocol.  

Bradley D. Chest 2016;00.

References

[15]

Cowie MR, Woehrle H, Wegscheider K, et al. Adaptive servo-ventilation for central sleep apnea in systolic heart failure. N Engl J Med. 2015;373:1095–1105.