NCT01965236

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2013

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

October 8, 2013

Last Update Submit

May 31, 2016

Conditions

Hypertension

Keywords

hypertension, sodium intake, left ventricular function

Outcome Measures

Primary Outcomes (1)

  • ultrasound volume, imaging "strain" and tonometry

    18 months

Study Arms (2)

Group 1

EXPERIMENTAL

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 chlorideDietary Supplement: Placebo

Group 2

EXPERIMENTAL

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 chlorideDietary Supplement: Placebo

Interventions

sodium chlorideDIETARY_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.

Group 1Group 2
PlaceboDIETARY_SUPPLEMENT
Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 without french insurance
  • Adult protected by the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lapeyronie University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Hypertension

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Guilhem DU CAYLAR

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 18, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

FR(1)