Laboratorio de Sono, Divisao de Pneumologia, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.
Unidade de Hipertensao, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.
Clinics (Sao Paulo). 2021 Sep 3;76:e2926. doi: 10.6061/clinics/2021/e2926. eCollection 2021.
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.
描述 MORPHEOS（未经治疗的高血压和阻塞性睡眠呼吸暂停患者的发病率）试验，并描述 COVID-19 大流行带来的挑战。
MORPHEOS 是一项多中心（n=6）随机对照试验，旨在评估在未经治疗的高血压（HTN）和中重度阻塞性睡眠呼吸暂停（OSA）成年患者中，使用持续气道正压通气（CPAP）或安慰剂（鼻贴）治疗 6 个月对血压（BP）降低的影响。纳入至少使用一种降压药物的患者。未经治疗的 HTN 通过 24 小时 ABPM 中的至少一个异常参数和服药后跑入期的药丸计数评估的≥80%的药物依从性来确认。OSA 通过每小时≥15 次呼吸暂停-低通气事件定义。主要共同终点是肱动脉血压（诊室和动态血压监测，ABPM）和中心血压。次要结局包括高血压介导的器官损伤（HMOD）至心脏、主动脉、眼睛和肾脏。我们从这项研究中预先指定了几项子研究。在第一个月每周就诊一次，之后每月就诊一次。计划的样本量为 176 例患者，但大流行阻止了这一最终目标。将从最终样本中计算事后功效分析。ClinicalTrials.gov：NCT02270658。
前 100 例患者主要为男性（n=69），年龄：52±10 岁，体重指数：32.7±3.9kg/m2，常伴有合并症。
MORPHEOS 试验具有独特的研究设计，包括跑入期、药丸计数和对未经治疗的 HTN 患者高血压介导的器官损伤的详细分析，这将有助于阐明 CPAP 治疗 OSA 的影响。
