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

NCT ID: NCT05640128

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperaldosteronism; Primary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aldosterone in HPLC-MS/MS,

Aldosterone in HPLC-MS/MS measurement

Group Type OTHER

Aldosterone in HPLC-MS/MS

Intervention Type OTHER

Aldosterone in HPLC-MS/MS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aldosterone in HPLC-MS/MS

Aldosterone in HPLC-MS/MS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CAEN University Hospital

Caen, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yves REZNIK

Role: primary

0231064585 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-209

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.