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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
Author(s) -
Lyons Owen D.,
Floras John S.,
Logan Alexander G.,
Beanlands Robert,
Cantolla Joaquin Durán,
Fitzpatrick Michael,
Fleetham John,
John Kimoff R.,
Leung Richard S.T.,
Lorenzi Filho Geraldo,
Mayer Pierre,
Mielniczuk Lisa,
Morrison Debra L.,
Ryan Clodagh M.,
Series Frederic,
Tomlinson George A.,
Woo Anna,
Arzt Michael,
Parthasarathy Sairam,
Redolfi Stefania,
Kasai Takatoshi,
Parati Gianfranco,
Delgado Diego H.,
Bradley T. Douglas
Publication year - 2017
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.790
Subject(s) - medicine , heart failure , ejection fraction , polysomnography , cardiology , atrial fibrillation , randomized controlled trial , central sleep apnea , clinical endpoint , implantable cardioverter defibrillator , apnea
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.