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Randomized Controlled Trial
. 2017 Apr;19(4):579-587.
doi: 10.1002/ejhf.790.

Design of the effect of adaptive servo-ventilation on survival and cardiovascular hospital admissions in patients with heart failure and sleep apnoea: the ADVENT-HF trial

Owen D Lyons  1 , John S Floras  2 , Alexander G Logan  2 , Robert Beanlands  3 , Joaquin Durán Cantolla  4 , Michael Fitzpatrick  5 , John Fleetham  6 , R John Kimoff  7 , Richard S T Leung  8 , Geraldo Lorenzi Filho  9 , Pierre Mayer  10 , Lisa Mielniczuk  3 , Debra L Morrison  11 , Clodagh M Ryan  2 , Frederic Series  12 , George A Tomlinson  2 , Anna Woo  2 , Michael Arzt  13 , Sairam Parthasarathy  14 , Stefania Redolfi  15 , Takatoshi Kasai  16 , Gianfranco Parati  17 , Diego H Delgado  2 , T Douglas Bradley  2 ; ADVENT-HF Investigators
Affiliations
Free article
Randomized Controlled Trial

Design of the effect of adaptive servo-ventilation on survival and cardiovascular hospital admissions in patients with heart failure and sleep apnoea: the ADVENT-HF trial

Owen D Lyons et al. Eur J Heart Fail. 2017 Apr.
Free article

Abstract

Introduction: Both types of sleep-disordered breathing (SDB), obstructive and central sleep apnoea (OSA and CSA, respectively), are common in patients with heart failure and reduced ejection fraction (HFrEF). In such patients, SDB is associated with increased cardiovascular morbidity and mortality but it remains uncertain whether treating SDB by adaptive servo-ventilation (ASV) in such patients reduces morbidity and mortality.

Aim: ADVENT-HF is designed to assess the effects of treating SDB with ASV on morbidity and mortality in patients with HFrEF.

Methods: ADVENT-HF is a multicentre, multinational, randomized, parallel-group, open-label trial with blinded assessment of endpoints of standard medical therapy for HFrEF alone vs. with the addition of ASV in patients with HFrEF and SDB. Patients with a history of HFrEF undergo echocardiography and polysomnography. Those with a left ventricular ejection fraction ≤45% and SDB (apnoea-hypopnoea index ≥15) are eligible. SDB is stratified into OSA with ≥50% of events obstructive or CSA with >50% of events central. Those with OSA must not have excessive daytime sleepiness (Epworth score of ≤10). Patients are then randomized to receive or not receive ASV. The primary outcome is the composite of all-cause mortality, cardiovascular hospital admissions, new-onset atrial fibrillation requiring anti-coagulation but not hospitalization, and delivery of an appropriate discharge from an implantable cardioverter-defibrillator not resulting in hospitalization during a maximum follow-up time of 5 years.

Conclusion: The ADVENT-HF trial will help to determine whether treating SDB by ASV in patients with HFrEF improves morbidity and mortality.

Keywords: Adaptive servo-ventilation; Cardiovascular hospital admissions; Central sleep apnoea; Heart failure; Mortality; Obstructive sleep apnoea; Sleep-disordered breathing.

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