The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic

Detalhes bibliográficos
Autor(a) principal: Cruz, Fernanda C.S.G.
Data de Publicação: 2021
Outros Autores: Drager, Luciano F., Queiróz, Daniel B.C., Souza, Gabriela A., Pedrosa, Rodrigo P., Patriota, Tarcya L.G Couto, Dórea, Egidio L., Vieira, Marcelo Luiz C., Righi, Camila G., Martinez, Denis, Silva, Geruza A. da, Silva, Giovanio V., Pio-Abreu, Andrea, Lotufo, Paulo A., Benseãor, Isabela M., Bortolotto, Luiz A., Fuchs, Flávio D., Lorenzi-Filho, Geraldo
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Clinics
Texto Completo: https://www.revistas.usp.br/clinics/article/view/213003
Resumo: OBJECTIVES: To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic. METHODS: MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658. RESULTS: The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m2 with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.
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spelling The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemicObstructive Sleep ApneaHypertensionCPAPOBJECTIVES: To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic. METHODS: MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658. RESULTS: The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m2 with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo2021-09-03info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/clinics/article/view/21300310.6061/clinics/2021/e2926Clinics; Vol. 76 (2021); e2926Clinics; v. 76 (2021); e2926Clinics; Vol. 76 (2021); e29261980-53221807-5932reponame:Clinicsinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/clinics/article/view/213003/195021Copyright (c) 2023 Clinicsinfo:eu-repo/semantics/openAccessCruz, Fernanda C.S.G.Drager, Luciano F.Queiróz, Daniel B.C.Souza, Gabriela A.Pedrosa, Rodrigo P.Patriota, Tarcya L.G CoutoDórea, Egidio L.Vieira, Marcelo Luiz C.Righi, Camila G.Martinez, DenisSilva, Geruza A. daSilva, Giovanio V.Pio-Abreu, AndreaLotufo, Paulo A.Benseãor, Isabela M.Bortolotto, Luiz A.Fuchs, Flávio D.Lorenzi-Filho, Geraldo2023-07-06T13:04:07Zoai:revistas.usp.br:article/213003Revistahttps://www.revistas.usp.br/clinicsPUBhttps://www.revistas.usp.br/clinics/oai||clinics@hc.fm.usp.br1980-53221807-5932opendoar:2023-07-06T13:04:07Clinics - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
title The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
spellingShingle The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
Cruz, Fernanda C.S.G.
Obstructive Sleep Apnea
Hypertension
CPAP
title_short The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
title_full The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
title_fullStr The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
title_full_unstemmed The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
title_sort The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic
author Cruz, Fernanda C.S.G.
author_facet Cruz, Fernanda C.S.G.
Drager, Luciano F.
Queiróz, Daniel B.C.
Souza, Gabriela A.
Pedrosa, Rodrigo P.
Patriota, Tarcya L.G Couto
Dórea, Egidio L.
Vieira, Marcelo Luiz C.
Righi, Camila G.
Martinez, Denis
Silva, Geruza A. da
Silva, Giovanio V.
Pio-Abreu, Andrea
Lotufo, Paulo A.
Benseãor, Isabela M.
Bortolotto, Luiz A.
Fuchs, Flávio D.
Lorenzi-Filho, Geraldo
author_role author
author2 Drager, Luciano F.
Queiróz, Daniel B.C.
Souza, Gabriela A.
Pedrosa, Rodrigo P.
Patriota, Tarcya L.G Couto
Dórea, Egidio L.
Vieira, Marcelo Luiz C.
Righi, Camila G.
Martinez, Denis
Silva, Geruza A. da
Silva, Giovanio V.
Pio-Abreu, Andrea
Lotufo, Paulo A.
Benseãor, Isabela M.
Bortolotto, Luiz A.
Fuchs, Flávio D.
Lorenzi-Filho, Geraldo
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Cruz, Fernanda C.S.G.
Drager, Luciano F.
Queiróz, Daniel B.C.
Souza, Gabriela A.
Pedrosa, Rodrigo P.
Patriota, Tarcya L.G Couto
Dórea, Egidio L.
Vieira, Marcelo Luiz C.
Righi, Camila G.
Martinez, Denis
Silva, Geruza A. da
Silva, Giovanio V.
Pio-Abreu, Andrea
Lotufo, Paulo A.
Benseãor, Isabela M.
Bortolotto, Luiz A.
Fuchs, Flávio D.
Lorenzi-Filho, Geraldo
dc.subject.por.fl_str_mv Obstructive Sleep Apnea
Hypertension
CPAP
topic Obstructive Sleep Apnea
Hypertension
CPAP
description OBJECTIVES: To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic. METHODS: MORPHEOS is a multicenter (n=6) randomized controlled trial designed to evaluate the blood pressure (BP) lowering effects of treatment with continuous positive airway pressure (CPAP) or placebo (nasal strips) for 6 months in adult patients with uncontrolled hypertension (HTN) and moderate-to-severe obstructive sleep apnea (OSA). Patients using at least one antihypertensive medication were included. Uncontrolled HTN was confirmed by at least one abnormal parameter in the 24-hour ABPM and ≥80% medication adherence evaluated by pill counting after the run-in period. OSA was defined by an apnea-hypopnea index ≥15 events/hours. The co-primary endpoints are brachial BP (office and ambulatory BP monitoring, ABPM) and central BP. Secondary outcomes include hypertension-mediated organ damage (HMOD) to heart, aorta, eye, and kidney. We pre-specified several sub-studies from this investigation. Visits occur once a week in the first month and once a month thereafter. The programmed sample size was 176 patients but the pandemic prevented this final target. A post-hoc power analysis will be calculated from the final sample. ClinicalTrials.gov: NCT02270658. RESULTS: The first 100 patients are predominantly males (n=69), age: 52±10 years, body mass index: 32.7±3.9 kg/m2 with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design including a run-in period; pill counting, and detailed analysis of hypertension-mediated organ damage in patients with uncontrolled HTN that will allow clarification of the impact of OSA treatment with CPAP.
publishDate 2021
dc.date.none.fl_str_mv 2021-09-03
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/clinics/article/view/213003
10.6061/clinics/2021/e2926
url https://www.revistas.usp.br/clinics/article/view/213003
identifier_str_mv 10.6061/clinics/2021/e2926
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/clinics/article/view/213003/195021
dc.rights.driver.fl_str_mv Copyright (c) 2023 Clinics
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2023 Clinics
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
publisher.none.fl_str_mv Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
dc.source.none.fl_str_mv Clinics; Vol. 76 (2021); e2926
Clinics; v. 76 (2021); e2926
Clinics; Vol. 76 (2021); e2926
1980-5322
1807-5932
reponame:Clinics
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Clinics
collection Clinics
repository.name.fl_str_mv Clinics - Universidade de São Paulo (USP)
repository.mail.fl_str_mv ||clinics@hc.fm.usp.br
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