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

NCT02129621 | Completed

• 1 other identifier: 2007-A01008-45
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

Lipocalin; mineralocorticoid receptor

Outcome Measures

Primary Outcomes (1)

• Lipocalin blood and urinary concentrations

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

  8 months

Interventions

Urinary and blood lipococalin levels determination PROCEDURE

Blood test on an empty stomach. Urinary taking on arrival in the service

Spironolactone DRUG

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Absence of social insurance
• For group 3
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (3)

Brabois Hospital

Nancy, 54000, France

Location

Georges Pompidou Hospital

Paris, 75015, France

Location

Unit of arterial high blood pressure of the Georges Pompidou Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Spironolactone

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Michel AZIZI, Pr

  Georges Pompidou Hospital, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 2, 2014

Record last verified: 2013-01

Locations

FR (3)