Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Changes in nocturnal systolic blood pressure
研究概览
简要总结
A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease.
详细描述
A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular disease. Patients with hypertension resistant of antihypertensive treatment have a high frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal pauses in breathing in this patients population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Binding not possible as patients needs to carry out dietary sodium restriction themselves.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •24h blood pressure > 130/80 mmHg under antihypertensive treatment with three agent, one of these being diuretic. Blood pressure measurement completed after observed intake of antihypertensive medication.
- •unchanged antihypertensive treatment for three months
- •estimated glomerular function >45 mL/min/1.73 m2
排除标准
- •Heart failure assessed from NYHA classification (grade 3-4)
- •Presence of clinically significant peripheral edema
- •In treatment for obstructive sleep apnea
- •Chronic obstructive pulmonary disease (FEV1 <50%)
- •Antihypertensive therapy that can not be taken once daily
- •Pregnancy or breastfeeding
- •Β-albumin <34 g / l
- •U-albumin creatinine ratio> 1000 mg / g
- •INR> 1.2 (if marevan treatment: ALAT> 200)
- •Gluten allergy (dietary guidelines are not adjusted to this group)
结局指标
主要结局
Changes in nocturnal systolic blood pressure
时间窗: from day 14 to day 28
Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
次要结局
- Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)(from day 14 to day 28)
- Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)(from day 14 to day 28)
- Changes in day:night sodium urinary sodium excretion(from day 14 to day 28)
- Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)(from day 14 to day 28)
- Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)(from day 14 to day 28)
研究者
Jesper Norgaard Bech
M.D., PhD, head of University Clinic in Nephrology and Hypertension, Regeional Hospital Vest Justland and Aarhus university
Regional Hospital Holstebro