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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01965236

Enrollment

Registered

2013-10-18

Start date

2013-05-31

Completion date

2016-03-31

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, sodium intake, left ventricular function

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.

Interventions

DIETARY_SUPPLEMENTsodium 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_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ultrasound volume, imaging strain and tonometry	18 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026