Cardiovascular DiseasesNCT02129621
Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human
A study testing Urinary and blood lipococalin levels determination and Spironolactone in people with Cardiovascular Diseases, run by Central Hospital, Nancy, France at 3 sites in France.
Trial summary
Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Urinary and blood lipococalin levels determination and Spironolactone
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 3 sitesFrance
- Study dates
- May 2010to Nov 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men having an age ranging between 18 and 35 years
- Unhurt subject of any acute pathology for more than 7 days
- Consent signed by the subject
- Men or women having an age ranging between 18 and 85 years
- Unhurt subject of any acute pathology for more than 7 days
- without any cardiovascular treatment
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- Consent signed by the subject
- Men or women having an age ranging between 18 and 85 years
- Subject with chronique renal insufficiency
- Consent signed by the subject
- Men or women having an age ranging between 30 and 60 years
- Hypertensive subject suffering from primary hyperaldosteronism defined by an aldosteron/renin ratio > 64 pmol/mL in position lying and an aldosteron level > 500pmol lying down (or > 550pmol/L seated or standing) or urinary aldosteron level > 63 nmol/24 hours; for whom
- Subjects having an indication for a monotherapy treatment by ALDACTONE (1 or 2 mg/kg/j)during preoperative period, possibly associated if need be with a calcic inhibitive treatment, central or alphabloquant treatment.
- Subject without other cardiovascular history (myocardic infarction, decompensation of cardiac insufficiency, intellectual vascular accident) and with a normal renal function according to the age,the sex and the blood value of creatinine by the formula MDRD (Flow of renal filtration > 60mL/min/1,73)
- Consent signed by the subject
Who cannot join
- Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg) or any cardiovascular history
- Subject presenting a known renal insufficiency
- Subject presenting a known anaemia (Hb < 12g/dl)
- Subject presenting a known diabetes
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Subject presenting a chronic liver disease
Show all 50Show fewer
- Subject presenting a connectivite: Rhumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Any medicinal treatment
- Subject participating in another protocol or in exclusion's period for another protocol
- Absence of social insurance
- For group 3
- Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg or > 160/95 mmHg after 60 years)
- Subject presenting a known renal insufficiency
- Subject presenting a known diabetes
- Woman who is pregnant
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Subject presenting a chronic liver disease
- Subject presenting a connectivite: Rhumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Subject presenting an effort angor or other coronaropathy
- Subject with antecedant of endarterectomy of carotid
- Subject with known abdominal aorta aneurism
- Subject participating in another protocol or in exclusion's period for another protocol
- Absence of social insurance
- For group 4
- Subject presenting a known diabetes
- Woman who is pregnant
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Subject presenting a chronic liver disease
- Subject presenting a connectivite: Rhumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Subject presenting an effort angor or other coronaropathy
- Subject with antecedant of endarterectomy of carotid
- Subject with known abdominal aorta aneurism
- Subject participating in another protocol or in exclusion's period for another protocol
- Absence of social insurance
- For the group 5
- Subject presenting others forms of high blood pressure (consumption of products or medicines which can facilitate or deteriorate the high blood pressure (alcohol, licorise (of whom the "pastis" without alcohol), anti-inflammatory drugs, corticosteroids, ciclosporin, erythropoiétin, cocain), hyperthyroidy, hypercorticism, chronic renal disease: urinary protein level < 0.3 g/l and clearance of the creatinine > 60ml/min/1.73m2), arterial renal stenosis
- Counter -indication of realization of a test of salt injection
- Current pregnancy
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
- Chronic liver disease
- Subject presenting a connectivite: Rheumatoid polyarthritis....
- Crohns disease
- Current tuberculosis
- Absence of social insurance
Trial locations and contacts
3 sites in 1 country.
France3 sites
Brabois Hospital
Nancy, 54000
Georges Pompidou Hospital
Paris, 75015
Unit of arterial high blood pressure of the Georges Pompidou Hospital
Paris, 75015
About this study
Official title: Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.
Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.
Read the detailed description
This study is broken up into 5 groups:
The first is a pre-analytical study to determinate optimum conditions for lipocalin samples.
The second focuses on intra-individual variations of lipocalin levels in blood and urine.
The third determinate the normal values of lipocalin in blood and urine. Fourthly, we study the role of renal function on serum and urines lipocalin levels.
Fifthly, we study the role of anti-aldosterone treatment on patients who suffer of primary hyperaldosteronism.
- Conditions
- Cardiovascular Diseases
- Being tested
- Urinary and blood lipococalin levels determination, Spironolactone
- Keywords
- Lipocalin, mineralocorticoid receptor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary and blood lipococalin levels determinationProcedure or surgery
Blood test on an empty stomach. Urinary taking on arrival in the service
SpironolactoneDrug
Also called ALDACTONE
For the group 5, at the time of the V0 visit, a treatment by aldactone will be set up (posology: 1 to 2 mg/kg).
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipocalin blood and urinary concentrations
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel AZIZI, Pr, Principal investigator, Georges Pompidou Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129621
- Sponsor's protocol ID
- 2007-A01008-45
- Status last verified
- Jan 2013
- First submitted
- 30 Apr 2014
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.
- ClinicalTrials.gov ID
- NCT02129621
- Acronym / sponsor ID
- 2007-A01008-45
- Conditions
- Cardiovascular Diseases
- Keywords
- Lipocalin, mineralocorticoid receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 May 2014 (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.
Aldosterone and its target the mineralocorticoid receptor are implied in development of cardiovascular disease such as arterial high blood pressure or cardiac failure. Serum aldosterone level is insufficient to know if the mineralocorticoid receptor is activated or not. The aim of this study is to identify biomarkers of mineralocorticoid receptor activity. The first "candidate biomarker" is Neutrophil gelatinase-associated lipocalin (NGAL) or "lipocalin" which being measured in blood or in the urine. According to scientific knowledge's evolution, others biomarkers could be tested later thanks to the blood or urinary samples taken during study.
Detailed description
This study is broken up into 5 groups:
The first is a pre-analytical study to determinate optimum conditions for lipocalin samples.
The second focuses on intra-individual variations of lipocalin levels in blood and urine.
The third determinate the normal values of lipocalin in blood and urine. Fourthly, we study the role of renal function on serum and urines lipocalin levels.
Fifthly, we study the role of anti-aldosterone treatment on patients who suffer of primary hyperaldosteronism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men having an age ranging between 18 and 35 years
- Unhurt subject of any acute pathology for more than 7 days
- Consent signed by the subject
- Men or women having an age ranging between 18 and 85 years
- Unhurt subject of any acute pathology for more than 7 days
Key exclusion criteria (50 listed)
- Subject presenting a known arterial high blood pressure (blood pressure > 140/90 mmHg) or any cardiovascular history
- Subject presenting a known renal insufficiency
- Subject presenting a known anaemia (Hb < 12g/dl)
- Subject presenting a known diabetes
- Subject presenting a cancer diagnosed less than 5 years previously or evolutionary cancer
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 |
|---|---|---|
| Urinary and blood lipococalin levels determinationBlood test on an empty stomach. Urinary taking on arrival in the service | Procedure or surgery | – |
| SpironolactoneAlso: ALDACTONEFor the group 5, at the time of the V0 visit, a treatment by aldactone will be set up (posology: 1 to 2 mg/kg). | Drug | – |
Primary outcome
Lipocalin blood and urinary concentrations
Time frame: 8 months
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
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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.
Michel AZIZI, Pr principal investigator
Georges Pompidou Hospital, Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary and blood lipococalin levels determination and Spironolactone in people with Cardiovascular Diseases, run by Central Hospital, Nancy, France at 3 sites in France.
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 15 inclusion and 50 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: finished, as of the sponsor's last update on 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lipocalin blood and urinary concentrations (time frame: 8 months). 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 2 May 2014.