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

Sponsor
University Hospital, Caen (Other)
Overall Status
Recruiting
CT.gov ID
NCT05640128
Collaborator
(none)
300
Enrollment
1
Location
1
Arm
72
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aldosterone in HPLC-MS/MS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Jan 2, 2018
Anticipated Primary Completion Date :
Jan 2, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CAEN University Hospital Caen France

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05640128
Other Study ID Numbers:
  • 17-209
First Posted:
Dec 7, 2022
Last Update Posted:
Dec 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hyperaldosteronism

Study Results

No Results Posted as of Dec 7, 2022