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
  Purpose

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 Intervention
Hypertension
Dietary Supplement: sodium chloride
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • ultrasound volume, imaging "strain" and tonometry [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965236

Contacts
Contact: Guilhem DU CAYLAR, PhD +33 4 67 33 84 43 g-du_caylar@chu-montpellier.fr

Locations
France
Lapeyronie University Hospital of Montpellier Recruiting
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

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01965236     History of Changes
Other Study ID Numbers: 8985
Study First Received: October 8, 2013
Last Updated: June 25, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014