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

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.

Bibliographic Details

Main Authors:	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
Format:	Digital revista
Language:	English
Published:	Faculdade de Medicina / USP 2021
Online Access:	http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1807-59322021000100307
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