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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: sodium chloride

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Lapeyronie University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Placebo; 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.
Experimental: 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.	Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ultrasound volume, imaging "strain" and tonometry	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Guilhem DU CAYLAR, Department of intern Medicine and arterial Hypertension Lapeyronie University Hospital of Montpellier, Montpellier, France, 34295

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: hypertension, sodium intake, left ventricular function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 8985 (CTEP)