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

Not Applicable

Recruiting

• Conditions: Hyperaldosteronism; Primary
• Interventions: Other: Aldosterone in HPLC-MS/MS

• Registration Number: NCT05640128
• Lead Sponsor: University Hospital, Caen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Status Verified: 2022-11
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Primary Completion: 2023-01-02
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aldosterone in HPLC-MS/MS,	Aldosterone in HPLC-MS/MS	Aldosterone in HPLC-MS/MS measurement

Primary Outcome Measures

Name	Time	Method
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.	baseline	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.

Trial Locations

Locations (1)

CAEN University Hospital; 🇫🇷 Caen, France