Genetic Determinant of Blood Pressure Sensitivity to Salt Intake

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Other: Diet Amiloride

• Registration Number: NCT01706887
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt retention by the kidney. The study address the consequence of a frequent genetic variation leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute a genetic predisposition to (or protection against) salt-sensitive hypertension.

Detailed Description

Subjects were submitted one week to a low sodium-high potassium diet, and then switch to a high sodium,-low potassium diet for two weeks. the last week, subject were taken a 20 MG daily dose of amiloride, a potassium sparing diuretic.

Study Timeline

• Study Start: 2007-04
• Status Verified: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-10-12
• Last Update Submitted: 2012-10-12
• Study First Posted: 2012-10-15
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 219

Inclusion Criteria

• healthy volunteers
• between 18 and 35 years odl
• BMI between 18 and 28 Kg per m2
• non smokers
• no active disease
• no alcool or drug abuse

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet Amiloride	Diet Amiloride	One week Low Na diet (10 mmol/d) followed by ine week high Na diet (200 mmol/d) followed by 2 weeks administration of amiloride (10 mg the 1 st week and the 20mg).

Primary Outcome Measures

Name	Time	Method
Difference in Blood Pressure among genotypes	24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks	24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks

Secondary Outcome Measures

Name	Time	Method
Ambulatory Blood Pressure (AMBP)	three weeks	24h AMBP was measured fourth : at the beginning of the study,at the end of the low sodium-high potassium diet, after one week under the high sodium-low potassium diet and at the end of amiloride treatment under high sodium-low potassium diet