An interventional study of Urinary and blood lipococalin levels determination and Spironolactone in Cardiovascular Diseases, sponsored by Central Hospital, Nancy, France. Completed at 3 sites in France. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-02.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 42 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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For the group 1 and 2
Inclusion criteria:
Exclusion criteria:
For group 3
Inclusion criteria:
Exclusion criteria:
For group 4
Inclusion criteria:
Exclusion criteria:
For the group 5
Inclusion Criteria:
Exclusion Criteria:
Blood test on an empty stomach. Urinary taking on arrival in the service
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).
Also known as: ALDACTONE
Lipocalin blood and urinary concentrations
Serum and urinary lipocalin concentrations will be evaluated using comercially available kits (Kits lipocalin-2/NGAL (NCAL20))
Time frame: 8 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France