NCT01706887

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
219

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2007

Longer than P75 for not_applicable hypertension

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
Last Updated

October 15, 2012

Status Verified

March 1, 2012

Enrollment Period

4.9 years

First QC Date

April 27, 2012

Last Update Submit

October 12, 2012

Conditions

Hypertension

Keywords

Nedd4-2blood pressurepolymorphismsalt intakebetween 18 and 35 years oldBMI between 18 and 28 Kg per m2no active diseaseno alcool or drug abuse or smoke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ambulatory Blood Pressure (AMBP)

    three weeks

Study Arms (1)

Diet Amiloride

EXPERIMENTAL

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

Interventions

Diet AmilorideOTHER

only arm of the trial

Diet Amiloride

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesChemically-Induced DisordersMental Disorders

Study Officials

  • Xavier Jeunemaître, PD, PhD

    genetic department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2012

First Posted

October 15, 2012

Study Start

April 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

October 15, 2012

Record last verified: 2012-03