Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring
研究概览
简要总结
Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension.
The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.
详细描述
Obstructive Sleep Apnea is highly prevalent in patients with resistant hypertension and several studies have assessed the effect of CPAP treatment on BP.
But only few studies have raised data about the effect of CPAP treatment on BP in patients with resistant hypertension.
Hypertension is moreover associated with increased arterial stiffness, but no data are available in patients with resistant hypertension.
The purpose of this study is to demonstrate that OSA has a major impact in resistant hypertension, whose effects on BP and arterial stiffness can partially be reversible with CPAP treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
- •Patient with severe OSA (apnea-hypopnea index > 30 or > or equal to 15 with excessive daytime sleepiness), or with mild to moderate OSA without excessive daytime sleepiness, or without OSA.
- •Ambulatory patient
排除标准
- •Body mass index ≥40 kg/m2
- •Other identifiable causes of hypertension
- •Contraindication to CPAP treatment or patient already treated with CPAP
结局指标
主要结局
Mean variation in BP at 6 months, assessed by 24h ambulatory BP monitoring
时间窗: 6 months from baseline assessment
次要结局
- OSA prevalence in patients with resistant hypertension(6 months)
- BP variability assessed by home self BP measurments(6 months)
- Arterial stiffness assessed by pulse wave velocity and QKD interval(6 months)
- Antihypertensive treatment consumption(6 months)
- CPAP treatment observance(6 months)