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

NCT05640128 | Unknown

• 1 other identifier: 17-209
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperaldosteronism; Primary

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Aldosterone in HPLC-MS/MS,

OTHER

Aldosterone in HPLC-MS/MS measurement

Other: Aldosterone in HPLC-MS/MS

Interventions

Aldosterone in HPLC-MS/MS OTHER

Aldosterone in HPLC-MS/MS

Aldosterone in HPLC-MS/MS,

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CAEN University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Aldosterone; Liquid Chromatography-Mass Spectrometry

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques; Mass Spectrometry

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: November 28, 2022
• First Posted: December 7, 2022
• Study Start: January 2, 2018
• Primary Completion: January 2, 2023
• Study Completion: January 1, 2024
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)