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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.; 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.
  • Cruz, Fernanda C.S.G.; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Laboratorio de Sono, Divisao de Pneumologia, Instituto do Coracao (InCor). Sao Paulo. BR
  • Drager, Luciano F.; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Unidade de Hipertensao, Instituto do Coracao (InCor). Sao Paulo. BR
  • Queiróz, Daniel B.C.; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Laboratorio de Sono, Divisao de Pneumologia, Instituto do Coracao (InCor). Sao Paulo. BR
  • Souza, Gabriela A.; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Laboratorio de Sono, Divisao de Pneumologia, Instituto do Coracao (InCor). Sao Paulo. BR
  • Pedrosa, Rodrigo P.; Universidade de Pernambuco. Laboratorio do Sono e Coracao, Pronto-Socorro Cardiologico de Pernambuco (PROCAPE). Recife. BR
  • Patriota, Tarcya L.G Couto; Universidade de Pernambuco. Laboratorio do Sono e Coracao, Pronto-Socorro Cardiologico de Pernambuco (PROCAPE). Recife. BR
  • Dórea, Egidio L.; Universidade de Sao Paulo. Hospital Universitario, Faculdade de Medicina FMUSP. Sao Paulo. BR
  • Vieira, Marcelo Luiz C.; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Unidade de Ecocardiografia, Instituto do Coracao (InCor). Sao Paulo. BR
  • Righi, Camila G.; Hospital de Clinicas de Porto Alegre (LIPES-HCPA). Laboratorio Interdisciplinar de Pesquisa em Sono. Porto Alegre. BR
  • Martinez, Denis; Hospital de Clinicas de Porto Alegre (LIPES-HCPA). Laboratorio Interdisciplinar de Pesquisa em Sono. Porto Alegre. BR
  • Silva, Geruza A. da; Universidade de Sao Paulo. Faculdade de Medicina de Ribeirao Preto. Ribeirao Preto. BR
  • Silva, Giovanio V.; Universidade de Sao Paulo. Hospital Universitario, Faculdade de Medicina FMUSP. Sao Paulo. BR
  • Pio-Abreu, Andrea; Universidade de Sao Paulo. Hospital Universitario, Faculdade de Medicina FMUSP. Sao Paulo. BR
  • Lotufo, Paulo A.; Universidade de Sao Paulo. Hospital Universitario, Faculdade de Medicina FMUSP. Sao Paulo. BR
  • Benseãor, Isabela M.; Universidade de Sao Paulo. Hospital Universitario, Faculdade de Medicina FMUSP. Sao Paulo. BR
  • Bortolotto, Luiz A.; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Unidade de Hipertensao, Instituto do Coracao (InCor). Sao Paulo. BR
  • Fuchs, Flávio D.; Hospital de Clinicas de Porto Alegre. Divisao de Cardiologia. Porto Alegre. BR
  • Lorenzi-Filho, Geraldo; Universidade de Sao Paulo. Hospital das Clinicas HCFMUSP, Faculdade de Medicina. Laboratorio de Sono, Divisao de Pneumologia, Instituto do Coracao (InCor). Sao Paulo. BR
Clinics ; 76: e2926, 2021. tab, graf
Article in English | LILACS | ID: biblio-1339699
ABSTRACT

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.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Sleep Apnea, Obstructive / COVID-19 / Hypertension Type of study: Controlled clinical trial Limits: Adult / Humans / Male Language: English Journal: Clinics Journal subject: Medicine Year: 2021 Type: Article Affiliation country: Brazil Institution/Affiliation country: Hospital de Clinicas de Porto Alegre (LIPES-HCPA)/BR / Hospital de Clinicas de Porto Alegre/BR / Universidade de Pernambuco/BR / Universidade de Sao Paulo/BR

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Full text: Available Index: LILACS (Americas) Main subject: Sleep Apnea, Obstructive / COVID-19 / Hypertension Type of study: Controlled clinical trial Limits: Adult / Humans / Male Language: English Journal: Clinics Journal subject: Medicine Year: 2021 Type: Article Affiliation country: Brazil Institution/Affiliation country: Hospital de Clinicas de Porto Alegre (LIPES-HCPA)/BR / Hospital de Clinicas de Porto Alegre/BR / Universidade de Pernambuco/BR / Universidade de Sao Paulo/BR