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
Clinics
;
76: e2926, 2021. tab, graf
Artigo
em Inglês
| 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.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Apneia Obstrutiva do Sono
/
COVID-19
/
Hipertensão
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Adulto
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Clinics
Assunto da revista:
Medicina
Ano de publicação:
2021
Tipo de documento:
Artigo
País de afiliação:
Brasil
Instituição/País de afiliação:
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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