NCT02270658已完成不适用
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 10
- 主要终点
- Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
研究概览
简要总结
MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
- •Current treatment with at least 1 antihypertensive drug
排除标准
- •Age <18 and >65 years
- •BMI ≥ 40 kg/m2
- •Heart failure, EF < 45%, acute myocardial infarction, stroke, significant valvular dysfunction
- •Chronic renal failure (serum creatinine > 2 mg/dL)
- •Use of cocaine, amphetamines, alcohol, illicit drugs
- •Use of sympathomimetics (decongestants, appetite suppressants)
- •Use of oral contraceptives and chronic use of NSAIDs
- •Pregnancy
- •Secondary causes of hypertension (other than sleep apnea)
结局指标
主要结局
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
时间窗: 6 months
次要结局
- Impact of OSA treatment with CPAP on target-organ damage(6 months)
- Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)(6 months)
- Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)(6 months)
- Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)(6 months)
研究者
Geraldo Lorenzi Filho
Principal Investigator
University of Sao Paulo General Hospital
研究点 (10)
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