Influence of Sodium Intake on Left Ventricular-arterial Coupling in Hypertension: Biomechanical Assessment and Modelisation of Left Ventricular Function With Arterial Pressure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- ultrasound volume, imaging "strain" and tonometry
研究概览
简要总结
The objective of the present study is to asses the effectiveness of the aorta-ventricular coupling according to low and high sodium intake in 28 controled hypertensive patients.
详细描述
Comparison of left ventricular function in two groups of 13 patients according to their different salt's consumption in double blind and crossover study. Performance estimation of the left ventricle by echocardiographic and central arterial pressure by tonometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Hypertension stage 1, with medium or high risk, when the treatment (mono or therapy without diuretics) is efficient, when the great pressure is reached (<140/90 mmHg)
- •High sodium intake (sodium urinary excretion for 24h (UNaV) > or = 170 mmol/24h before visit 0
- •Limited sodium intake objective (UNaV<85 mmol/24h)attempted at the end of the limited sodium intake period of 2 weeks
- •Patients aged between 18 and 80 years
- •Subject has given written informed consent
- •Subject has subscribed a health care insurance
排除标准
- •Secondary hypertension
- •Complications associated with the arterial hypertension : history of cardiovascular diseases or myocardial infarction, cerebrovascular accident, coronary disease, ...
- •Arterial hypertension associated with cardiopathy
- •Arterial hypertension associated with nephropathy
- •Arterial hypertension associated with diabetes
- •Measure of central arterial pressure by tonometry is impossible
- •Cardiac echogenicity is not satisfactory for the analysis of left ventricular loop analysis
- •Patient refuses informed consent
- •Follow-up impossible for 15 weeks
- •Pregnant or women without efficacy contraception
- •Patient without freedom by administration decision
- •Patient in exclusion period
- •Patient without french insurance
- •Adult protected by the law
研究组 & 干预措施
Group 1
Patients are given 5 pills (1 g per pill) of sodium chloride per day for 6 weeks. After a one-week wash out period, a second period of 6 weeks is started with 5 placebo (microcrystalline cellulose) pills per day.
干预措施: Placebo (Dietary Supplement)
Group 2
Patients are given 5 placebo (microcrystalline cellulose) pills per day for 6 weeks. After a one-week wash out period, a second period of 6 weeks is started with 5 pills (1 g per pill) of sodium chloride per day.
干预措施: Placebo (Dietary Supplement)
Group 2
Patients are given 5 placebo (microcrystalline cellulose) pills per day for 6 weeks. After a one-week wash out period, a second period of 6 weeks is started with 5 pills (1 g per pill) of sodium chloride per day.
干预措施: sodium chloride (Dietary Supplement)
Group 1
Patients are given 5 pills (1 g per pill) of sodium chloride per day for 6 weeks. After a one-week wash out period, a second period of 6 weeks is started with 5 placebo (microcrystalline cellulose) pills per day.
干预措施: sodium chloride (Dietary Supplement)
结局指标
主要结局
ultrasound volume, imaging "strain" and tonometry
时间窗: 18 months
次要结局
未报告次要终点