Trial | NCT01965236  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    12
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.
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.
Study Started
May 31
2013
Primary Completion
Mar 31
2016
Study Completion
Mar 31
2016
Last Update
Jun 01
2016
Estimate

Dietary Supplement sodium chloride

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 Placebo

Group 1 Experimental

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.

Group 2 Experimental

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.

Criteria 

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
No Results Posted