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

Central Hospital, Nancy, France

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Procedure: Urinary and blood lipococalin levels determination

Drug: Spironolactone

Study type

Interventional

Funder types

Other

Identifiers

NCT02129621

2007-A01008-45

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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