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
Autor(a) principal: | |
---|---|
Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , , , , , , |
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. |
id |
USP-19_8f08f7a0753c9f67f030d1be0844dbd0 |
---|---|
oai_identifier_str |
oai:revistas.usp.br:article/213003 |
network_acronym_str |
USP-19 |
network_name_str |
Clinics |
repository_id_str |
|
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 |
_version_ |
1800222766205501440 |