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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
Authors: CRUZ, Fernanda C. S. G.DRAGER, Luciano F.QUEIROZ, Daniel B. C.SOUZA, Gabriela A.PEDROSA, Rodrigo P.PATRIOTA, Tarcya L. G. CoutoDOREA, Egidio L.VIEIRA, Marcelo Luiz C.RIGHI, Camila G.MARTINEZ, DenisSILVA, Geruza A. daV, Giovanio SilvaPIO-ABREU, AndreaLOTUFO, Paulo A.BENSEAOR, Isabela M.BORTOLOTTO, Luiz A.FUCHS, Flavio D.LORENZI-FILHO, Geraldo
Citation: CLINICS, v.76, article ID e2926, 8p, 2021
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. RESULTS: The first 100 patients are predominantly males (n=69), age: 52 +/- 10 years, body mass index: 32.7 +/- 3.9 kg/m(2) with frequent co-morbidities. CONCLUSIONS: The MORPHEOS trial has a unique study design inclu ding 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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Artigos e Materiais de Revistas Científicas - COVID-19

Artigos e Materiais de Revistas Científicas - FM/MCM
Departamento de Clínica Médica - FM/MCM

Artigos e Materiais de Revistas Científicas - FM/MCP
Departamento de Cardio-Pneumologia - FM/MCP

Artigos e Materiais de Revistas Científicas - HC/ICHC
Instituto Central - HC/ICHC

Artigos e Materiais de Revistas Científicas - HC/InCor
Instituto do Coração - HC/InCor

Artigos e Materiais de Revistas Científicas - HU
Hospital Universitário - HU

Artigos e Materiais de Revistas Científicas - LIM/20
LIM/20 - Laboratório de Terapêutica Experimental

Artigos e Materiais de Revistas Científicas - LIM/63
LIM/63 - Laboratório de Investigação Médica em Sono

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