The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea Index
研究概览
简要总结
Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.
详细描述
This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 40 years of age
- •Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)
排除标准
- •Low life expectancy
- •Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs
- •Pregnancy
- •Established cardiovascular disease (myocardial infarction
- •Heart failure)
- •Use of more than one drug for hypertension
- •Secondary hypertension
- •Participation in other clinical trial in previous 6 months
研究组 & 干预措施
Diuretics
Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
干预措施: Diuretics (Drug)
Calcium Channel Blockers
Amlodipine 10 mg daily, taking in the morning
干预措施: Calcium Channel Blockers (Drug)
结局指标
主要结局
Apnea-Hypopnea Index
时间窗: 8 weeks
Number of apneas/hour
Blood Pressure
时间窗: 8 weeks
次要结局
- Adverse events(8 weeks)
- Somnolence scale (Epworth) and ventilatory parameters(8 weeks)
- C reactive protein(8 weeks)