Effects of suvorexant on sleep apnea in patients with heart failure: A protocol of crossover pilot trial.
Azepines
/ therapeutic use
Cross-Over Studies
Equivalence Trials as Topic
Female
Heart Failure
/ complications
Humans
Male
Middle Aged
Pilot Projects
Polysomnography
Randomized Controlled Trials as Topic
Sleep
/ drug effects
Sleep Aids, Pharmaceutical
/ therapeutic use
Sleep Apnea Syndromes
/ complications
Sleep Initiation and Maintenance Disorders
/ complications
Treatment Outcome
Triazoles
/ therapeutic use
Apnea–hypopnea index
Heart failure
Sleep-disordered breathing
Suvorexant
Journal
Journal of cardiology
ISSN: 1876-4738
Titre abrégé: J Cardiol
Pays: Netherlands
ID NLM: 8804703
Informations de publication
Date de publication:
Jul 2019
Jul 2019
Historique:
received:
23
11
2018
revised:
23
12
2018
accepted:
30
12
2018
pubmed:
10
2
2019
medline:
24
6
2020
entrez:
10
2
2019
Statut:
ppublish
Résumé
Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF. The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant. The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters short- and long-term clinical outcomes by providing longer and better sleep in patients with HF.
Sections du résumé
BACKGROUND
BACKGROUND
Suvorexant, an orexin receptor antagonist, is known as a safe and effective sleep medication. Many patients with heart failure (HF) have sleep-disordered breathing (SDB) and are short sleepers, and it is unknown whether suvorexant is effective in HF patients and can improve insomnia safely. The aim of this study is to examine the effect of suvorexant on SDB in patients with HF.
METHODS
METHODS
The Heart Failure with Insomnia and Suvorexant trial of Juntendo University Hospital and Juntendo Shizuoka Hospital (J-FLAVOR trial) is a multicenter trial with a randomized double crossover design. We will enroll a total of 30 HF patients treated in the Juntendo University Hospital and Juntendo Shizuoka Hospital. Eligible patients will undergo portable sleep monitoring twice with or without oral administration of suvorexant in a randomly assigned order. Before the study night, patients in the suvorexant first group will receive suvorexant for 4 consecutive days. There are at least 3 wash-out days between the study nights with and without suvorexant. Primary outcome measures of the non-inferiority trial of suvorexant include the apnea-hypopnea index and the severity of SDB, and the results will be compared between the study nights with and without suvorexant.
CONCLUSION
CONCLUSIONS
The present study can determine whether suvorexant can be used in HF patients without affecting their SDB. This is a pilot study to primarily assess whether suvorexant affects the severity of SDB in patients with HF. Therefore, further study is warranted to investigate whether suvorexant alters short- and long-term clinical outcomes by providing longer and better sleep in patients with HF.
Identifiants
pubmed: 30737183
pii: S0914-5087(19)30008-5
doi: 10.1016/j.jjcc.2018.12.021
pii:
doi:
Substances chimiques
Azepines
0
Sleep Aids, Pharmaceutical
0
Triazoles
0
suvorexant
081L192FO9
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
90-94Informations de copyright
Copyright © 2019 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.