医学
持续气道正压
阻塞性睡眠呼吸暂停
血压
体质指数
内科学
睡眠呼吸暂停
动态血压
气道正压
随机对照试验
儿科
药丸
心脏病学
药理学
作者
F. C. S. G. Cruz,Luciano F. Drager,Daniel B.C. Queiróz,Gabriela A. Souza,Rodrigo Pinto Pedrosa,Tarcya L. G. Couto Patriota,Egı́dio Lima Dórea,Marcelo Luiz Campos Vieira,Camila Gosenheimer Righi,Dênis Martinez,Geruza A. da Silva,Giovanio V. Silva,Andrea Pio-Abreu,Paulo A Lotufo,Isabela M. Benseñor,Luiz Aparecido Bortolotto,Flávio Danni Fuchs,Geraldo Lorenzi‐Filho
出处
期刊:Clinics
[Fundacao Faculdade de Medicina]
日期:2021-01-01
卷期号:76: e2926-e2926
标识
DOI:10.6061/clinics/2021/e2926
摘要
To describe the MORPHEOS (Morbidity in patients with uncontrolled HTN and OSA) trial, and describe the challenges imposed by the COVID-19 pandemic.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.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.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.
科研通智能强力驱动
Strongly Powered by AbleSci AI