Influence of Sodium Intake on Left Ventricular-arterial Coupling

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Dietary Supplement: sodium chloride; Dietary Supplement: Placebo

• Registration Number: NCT01965236
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-18
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-31
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Placebo	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.
Group 1	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.
Group 1	Placebo	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	sodium chloride	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.

Primary Outcome Measures

Name	Time	Method
ultrasound volume, imaging "strain" and tonometry	18 months

Trial Locations

Locations (1)

Lapeyronie University Hospital of Montpellier; 🇫🇷 Montpellier, France