Influence of Sodium Intake on Left Ventricular-arterial Coupling

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: sodium chloride
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Dietary Supplement: sodium chloride<br>* 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.<br>Dietary Supplement: Placebo<br> <br> |
| Experimental: Group 2<br>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. | Dietary Supplement: sodium chloride<br>* 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.<br>Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound volume, imaging strain and tonometry |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, sodium intake, left ventricular function