Hypothesis
Treating predominantly central sleep apnea with adaptive servo-ventilation would improve outcomes in heart failure with reduced ejection fraction.
What failed
In 1,325 patients the primary endpoint did not differ (54.1% vs 50.8%, HR 1.13, P=0.10), and all-cause mortality was significantly higher with servo-ventilation (HR 1.28, P=0.01), as was cardiovascular death (HR 1.34, P=0.006).
Broken assumption
Suppressing central sleep apnea improves outcomes in heart failure with reduced ejection fraction.
- Target engaged
- Yes
Why
The device did its job on the target — apnea-hypopnea index fell to 6.6 events an hour — but suppressing central apnea did not help these patients and was associated with more deaths.
From the published paper: Cowie MR, Woehrle H, Wegscheider K, et al. (SERVE-HF). N Engl J Med, 2015. NCT00733343 ↗