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Genetic Determinant of Blood Pressure Sensitivity to Salt Intake (JEU004)

This study has been terminated.
(end of recruitment period was reach)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01706887
First received: April 27, 2012
Last updated: October 12, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Other: Diet Amiloride

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Difference in Blood Pressure among genotypes [ Time Frame: 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks


Secondary Outcome Measures:
  • Ambulatory Blood Pressure (AMBP) [ Time Frame: three weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 219
Study Start Date: April 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
 Other: Diet Amiloride
only arm of the trial
Other Name: Diet Amiloride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706887

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Xavier Jeunemaître, PD, PhD genetic department
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01706887     History of Changes
Other Study ID Numbers: P060215
Study First Received: April 27, 2012
Last Updated: October 12, 2012
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Nedd4-2
blood pressure
polymorphism
salt intake
 between 18 and 35 years old
BMI between 18 and 28 Kg per m2
no active disease
no alcool or drug abuse or smoke

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amiloride
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013