Determination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism

Hyperaldosteronism; Primary Clinical Trial

— DAPS  

Official title:

Determination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640128
• Other study ID #: 17-209
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: January 2024

Study information

• Verified date: November 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

collaborative work within 2 hospitals at the CHU of Caen, at the CHRU of Lille, concerning the evaluation of the biological markers of primary hyperaldosteronism (PAH) with the dosage of aldosterone in LC -MS/MS, which is performed in both centers, with two different techniques. The main objective is to define the range of Aldosterone concentrations in LC MS/MS, of renin in an automated method, in populations of healthy volunteers, essential hypertensives, and hypertensives with primary hyperaldosteronism. , in order to establish a threshold for the screening of PAH by the RAR, and for the confirmation of PAH by a dynamic test with an Aldosterone threshold post salt load test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2024
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients (18-75 years old) with moderate to severe hypertension, which justifies carrying out an etiological assessment in a hospital environment.
• Assessment carried out in compliance with the standardized measurement conditions of the RAR defined by the SFE consensus,
• Signature of a written consent by the patient

Exclusion Criteria:

• Patient on antihypertensive treatment other than alpha-blockers, calcium channel blockers or centrally acting antihypertensive
• Etiology of secondary hypertension other than PAH

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hyperaldosteronism; Primary

Intervention

Other:
• Aldosterone in HPLC-MS/MS
Aldosterone in HPLC-MS/MS

Locations

Country	Name	City	State
France	CAEN University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aldosterone values in LC-MS/MS (and renin) and RAR calculation and calculation of an RAR threshold for PAH screening which differentiates between essential hypertension and PAH.	Define the range of concentrations of Aldosterone in LC MS/MS, of renin in an automated immunological method with calculation of the RAR, in populations of healthy volunteers, essential hypertensives, and hypertensives with primary hyperaldosteronism , in order to establish a threshold for the detection of PAH by the RAR, and for the confirmation of PAH by a dynamic test of confirmation by Aldosterone.	baseline