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Influence of Sodium Intake on Left Ventricular-arterial Coupling

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ClinicalTrials.gov Identifier: NCT01965236
Recruitment Status : Terminated
First Posted : October 18, 2013
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hypertension Dietary Supplement: sodium chloride Dietary Supplement: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Sodium Intake on Left Ventricular-arterial Coupling in Hypertension: Biomechanical Assessment and Modelisation of Left Ventricular Function With Arterial Pressure
Study Start Date : May 2013
Primary Completion Date : March 2016
Study Completion Date : March 2016

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U.S. FDA Resources

Arms and Interventions

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: 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 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: 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


Outcome Measures

Primary Outcome Measures :
  1. ultrasound volume, imaging "strain" and tonometry [ Time Frame: 18 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965236


Locations
France
Lapeyronie University Hospital of Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Guilhem DU CAYLAR Department of intern Medicine and arterial Hypertension Lapeyronie University Hospital of Montpellier, Montpellier, France, 34295
More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01965236     History of Changes
Other Study ID Numbers: 8985
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Keywords provided by University Hospital, Montpellier:
hypertension, sodium intake, left ventricular function

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases