Influence of Sodium Intake on Left Ventricular-arterial Coupling

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01965236
• Other study ID #: 8985
• Status: Terminated
• Phase: N/A
• First received: October 8, 2013
• Last updated: May 31, 2016
• Start date: May 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• Placebo

Locations

Country	Name	City	State
France	Lapeyronie University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasound volume, imaging "strain" and tonometry		18 months	No