Genetic Determinant of Blood Pressure Sensitivity to Salt Intake

Hypertension Clinical Trial

— JEU004  

Official title:

Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01706887
• Other study ID #: P060215
• Status: Terminated
• Phase: N/A
• First received: April 27, 2012
• Last updated: October 12, 2012
• Start date: April 2007
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 219
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Diet Amiloride
only arm of the trial

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Ambulatory Blood Pressure (AMBP)	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	three weeks	No