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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05640128
Other study ID # 17-209
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2018
Est. completion date January 2024

Study information

Verified date November 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date January 2024
Est. primary completion date January 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Aldosterone in HPLC-MS/MS
Aldosterone in HPLC-MS/MS

Locations

Country Name City State
France CAEN University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03155139 - Primary Aldosteronism In Hypertensive Patients in China
Withdrawn NCT04556279 - Investigating Salt Taste Threshold in Patients Being Investigated for Primary Hyperaldosteronism Before and After Treatment.