Influence of Sodium Intake on Left Ventricular-arterial Coupling

NCT ID: NCT01965236

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

sodium chloride

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

sodium chloride

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guilhem DU CAYLAR

Role: PRINCIPAL_INVESTIGATOR

Department of intern Medicine and arterial Hypertension Lapeyronie University Hospital of Montpellier, Montpellier, France, 34295

Locations

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Lapeyronie University Hospital of Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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8985

Identifier Type: -

Identifier Source: org_study_id

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