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Search of Biomarkers of Mineralocorticoid Receiver Activity : the Value of Neutrophil Gelatinase Associated Lipocalin (NGAL)in Serum or Urine in Human

1 de mayo de 2014 actualizado por: Central Hospital, Nancy, France

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.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

42

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Nancy, Francia, 54000
        • Brabois Hospital
      • Paris, Francia, 75015
        • Georges Pompidou Hospital
      • Paris, Francia, 75015
        • Unit of arterial high blood pressure of the Georges Pompidou Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
8 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Michel AZIZI, Pr, Georges Pompidou Hospital, Paris

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2010

Finalización primaria (Actual)

1 de noviembre de 2012

Finalización del estudio (Actual)

1 de noviembre de 2012

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

1 de mayo de 2014

Publicado por primera vez (Estimar)

2 de mayo de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

1 de mayo de 2014

Última verificación

1 de enero de 2013

Más información

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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