Academic Journal
Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial
| العنوان: | Adaptive servo-ventilation for sleep-disordered breathing in patients with heart failure with reduced ejection fraction (ADVENT-HF): a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial |
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| المؤلفون: | Bradley T. D., Logan A. G., Lorenzi Filho G., Kimoff R. J., Duran Cantolla J., Arzt M., Redolfi S., Parati G., Kasai T., Dunlap M. E., Delgado D., Yatsu S., Bertolami A., Pedrosa R., Tomlinson G., Marin Trigo J. M., Tantucci C., Floras J. S. |
| المساهمون: | Bradley, T. D., Logan, A. G., Lorenzi Filho, G., Kimoff, R. J., Duran Cantolla, J., Arzt, M., Redolfi, S., Parati, G., Kasai, T., Dunlap, M. E., Delgado, D., Yatsu, S., Bertolami, A., Pedrosa, R., Tomlinson, G., Marin Trigo, J. M., Tantucci, C., Floras, J. S. |
| سنة النشر: | 2024 |
| المجموعة: | Università degli Studi di Cagliari: UNICA IRIS |
| الوصف: | Background: In patients with heart failure and reduced ejection fraction, sleep-disordered breathing, comprising obstructive sleep apnoea (OSA) and central sleep apnoea (CSA), is associated with increased morbidity, mortality, and sleep disruption. We hypothesised that treating sleep-disordered breathing with a peak-flow triggered adaptive servo-ventilation (ASV) device would improve cardiovascular outcomes in patients with heart failure and reduced ejection fraction. Methods: We conducted a multicentre, multinational, parallel-group, open-label, phase 3 randomised controlled trial of peak-flow triggered ASV in patients aged 18 years or older with heart failure and reduced ejection fraction (left ventricular ejection fraction ≤45%) who were stabilised on optimal medical therapy with co-existing sleep-disordered breathing (apnoea-hypopnoea index [AHI] ≥15 events/h of sleep), with concealed allocation and blinded outcome assessments. The trial was carried out at 49 hospitals in nine countries. Sleep-disordered breathing was stratified into predominantly OSA with an Epworth Sleepiness Scale score of 10 or lower or predominantly CSA. Participants were randomly assigned to standard optimal treatment alone or standard optimal treatment with the addition of ASV (1:1), stratified by study site and sleep apnoea type (ie, CSA or OSA), with permuted blocks of sizes 4 and 6 in random order. Clinical evaluations were performed and Minnesota Living with Heart Failure Questionnaire, Epworth Sleepiness Scale, and New York Heart Association class were assessed at months 1, 3, and 6 following randomisation and every 6 months thereafter to a maximum of 5 years. The primary endpoint was the cumulative incidence of the composite of all-cause mortality, first admission to hospital for a cardiovascular reason, new onset atrial fibrillation or flutter, and delivery of an appropriate cardioverter-defibrillator shock. All-cause mortality was a secondary endpoint. Analysis for the primary outcome was done in the intention-to-treat ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/38142697; info:eu-repo/semantics/altIdentifier/wos/WOS:001174845500001; volume:12; issue:2; firstpage:153; lastpage:166; numberofpages:14; journal:THE LANCET RESPIRATORY MEDICINE; https://hdl.handle.net/11584/415463 |
| DOI: | 10.1016/S2213-2600(23)00374-0 |
| الاتاحة: | https://hdl.handle.net/11584/415463 https://doi.org/10.1016/S2213-2600(23)00374-0 |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.95BE3AD2 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S2213-2600(23)00374-0 |
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