Back to resultsDetermination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism (DAPS)
Primary Purpose
Hyperaldosteronism; Primary
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aldosterone in HPLC-MS/MS
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyperaldosteronism; Primary
Eligibility Criteria
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
Sites / Locations
- CAEN University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Aldosterone in HPLC-MS/MS,
Arm Description
Aldosterone in HPLC-MS/MS measurement
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05640128
First Posted
November 28, 2022
Last Updated
November 28, 2022
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT05640128
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 2, 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperaldosteronism; Primary
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aldosterone in HPLC-MS/MS,
Arm Type
Other
Arm Description
Aldosterone in HPLC-MS/MS measurement
Intervention Type
Other
Intervention Name(s)
Aldosterone in HPLC-MS/MS
Intervention Description
Aldosterone in HPLC-MS/MS
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CAEN University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves REZNIK
Phone
0231064585
Ext
+33
Email
reznik-y@chu-caen.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determination of Threshold Values of Aldosterone in HPLC-MS/MS, of Renin and of the Aldosterone / Renin Ratio for the Diagnosis of Primary Hyperaldosteronism
We'll reach out to this number within 24 hrs