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

November 28, 2022 updated by: University Hospital, Caen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Recruiting
        • CAEN University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Aldosterone in HPLC-MS/MS,
Aldosterone in HPLC-MS/MS measurement
Other: Aldosterone in HPLC-MS/MS
Aldosterone in HPLC-MS/MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Anticipated)

January 2, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

November 28, 2022

First Posted (Estimate)

December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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