HypertensionJEU004NCT01706887
Genetic Determinant of Blood Pressure Sensitivity to Salt Intake
A study testing Diet Amiloride in people with Hypertension, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Diet Amiloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Diet Amiloride
- Keywords
- 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
- Medical subject headings
- Hypertension, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet AmilorideOther
only arm of the trial
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Diet Amiloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Blood Pressure among genotypes
24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
Measured: 24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
Secondary outcomes (1)
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
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startApr 2007
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: end of recruitment period was reach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Jeunemaître, PD, PhD, Principal investigator, genetic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706887
- Sponsor's protocol ID
- P060215
- Acronym
- JEU004
- Status last verified
- Mar 2012
- First submitted
- 27 Apr 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Pharmacological and Biological Investigations of a Polymorphism of Nedd4 , a Regulatory Protein of the Epithelial Sodium Channel
- ClinicalTrials.gov ID
- NCT01706887
- Acronym / sponsor ID
- JEU004 / P060215
- Conditions
- Hypertension
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of recruitment period was reach
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet Amiloride | Experimental | Other: Diet AmilorideOne 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy volunteers
- between 18 and 35 years odl
- BMI between 18 and 28 Kg per m2
- non smokers
- no active disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet Amilorideonly arm of the trial | Other | Diet Amiloride |
Primary outcome
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
24h AMBP will be measured weekly for the duration of study, an expected average of 3 weeks
1 secondary outcome
Ambulatory Blood Pressure (AMBP)
Time frame: three weeks
Results and safety
The study was stopped early (reason given: end of recruitment period was reach). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Jeunemaître, PD, PhD principal investigator
genetic department
Questions about this trial
What is this clinical trial studying?
A study testing Diet Amiloride in people with Hypertension, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of recruitment period was reach). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2012.