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临床试验/NCT01965236
NCT01965236终止不适用

Influence of Sodium Intake on Left Ventricular-arterial Coupling in Hypertension: Biomechanical Assessment and Modelisation of Left Ventricular Function With Arterial Pressure

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
2
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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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