- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nancy, Francia, 54000
- Brabois Hospital
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Paris, Francia, 75015
- Georges Pompidou Hospital
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Paris, Francia, 75015
- Unit of arterial high blood pressure of the Georges Pompidou Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Lipocalin blood and urinary concentrations
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michel AZIZI, Pr, Georges Pompidou Hospital, Paris
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2007-A01008-45
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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