- Question
- Does treating sleep-disordered breathing with adaptive servo-ventilation (ASV) improve cardiovascular outcomes in patients with heart failure and reduced ejection fraction?
- Design
- Phase 3, multicentre, multinational, parallel-group, open-label trial with concealed 1:1 randomisation and blinded outcome assessment, conducted at 49 hospitals in nine countries. A total of 731 patients were randomised, with a mean follow-up of 3.6 years; enrolment and the trial ended early because of COVID-19 restrictions and a device recall.
- Population
- Adults with heart failure and left ventricular ejection fraction ≤45%, stabilised on optimal medical therapy, with sleep-disordered breathing (apnoea-hypopnoea index ≥15 events/h), either obstructive sleep apnoea (with low sleepiness) or predominantly central sleep apnoea.
- Intervention
- Standard optimal medical therapy plus peak-flow triggered ASV.
- Control
- Standard optimal medical therapy alone.
- Primary outcome
- Cumulative incidence of the composite of all-cause mortality, first cardiovascular hospital admission, new-onset atrial fibrillation or flutter, and appropriate defibrillator shock.
- Results
- ASV had no effect on the primary outcome (180 events in the control group vs 166 in the ASV group; HR 0.95, 95% CI 0.77-1.18; p=0.67). All-cause mortality also did not differ (88 vs 76 deaths; HR 0.89, 95% CI 0.66-1.21; p=0.47).
- Safety
- No safety issues related to ASV use were identified.
- Conclusion
- In patients with heart failure with reduced ejection fraction and sleep-disordered breathing, ASV safely eliminated the disordered breathing but did not improve the composite outcome or mortality.
- Why it matters
- The trial showed that correcting sleep apnoea with ASV does not translate into clinical benefit in this population, so it does not support its use to improve prognosis, even though the device effectively controls respiratory events.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026