Influence of Sodium Intake on Left Ventricular-arterial Coupling

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01965236
First received: October 8, 2013
Last updated: June 25, 2014
Last verified: June 2014

October 8, 2013
June 25, 2014
May 2013
December 2015   (final data collection date for primary outcome measure)
ultrasound volume, imaging "strain" and tonometry [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01965236 on ClinicalTrials.gov Archive Site
Not Provided
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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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • 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
  • 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.
    Interventions:
    • Dietary Supplement: sodium chloride
    • Dietary Supplement: Placebo
  • 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.
    Interventions:
    • Dietary Supplement: sodium chloride
    • Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
June 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Guilhem DU CAYLAR, PhD +33 4 67 33 84 43 g-du_caylar@chu-montpellier.fr
France
 
NCT01965236
8985
No
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Guilhem DU CAYLAR Department of intern Medicine and arterial Hypertension Lapeyronie University Hospital of Montpellier, Montpellier, France, 34295
University Hospital, Montpellier
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP