- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02129621
Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human
Prospective Study of Neutrophil Gelatinase Associated Lipocalin (NGAL)as a Biomarker of Mineralocorticoid Receiver Activity in Human: Proof of Concept.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Nancy, France, 54000
- Brabois Hospital
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Paris, France, 75015
- Georges Pompidou Hospital
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Paris, France, 75015
- Unit of arterial high blood pressure of the Georges Pompidou Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
For the group 1 and 2
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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
Inclusion criteria:
- 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
- Consent signed by the subject
Exclusion criteria:
- 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
Inclusion criteria:
- Men or women having an age ranging between 18 and 85 years
- Subject with chronique renal insufficiency
- Consent signed by the subject
Exclusion criteria:
- 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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Lipocalin blood and urinary concentrations
Délai: 8 months
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Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
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8 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michel AZIZI, Pr, Georges Pompidou Hospital, Paris
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2007-A01008-45
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