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Influence of Sodium Intake on Left Ventricular-arterial Coupling

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sodium chloride
Placebo
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, sodium intake, left ventricular function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lapeyronie University Hospital of Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ultrasound volume, imaging "strain" and tonometry

Secondary Outcome Measures

Full Information

First Posted
October 8, 2013
Last Updated
May 31, 2016
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT01965236
Brief Title
Influence of Sodium Intake on Left Ventricular-arterial Coupling
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, sodium intake, left ventricular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
sodium chloride
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
ultrasound volume, imaging "strain" and tonometry
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guilhem DU CAYLAR
Organizational Affiliation
Department of intern Medicine and arterial Hypertension Lapeyronie University Hospital of Montpellier, Montpellier, France, 34295
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lapeyronie University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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Influence of Sodium Intake on Left Ventricular-arterial Coupling

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