NCT05959863

Primary Aldosteronism LC-MS/MS-specific Cutoffs

LC-MS/MS-specific Cutoffs for Screening and Confirmatory Testing of Primary Aldosteronism: A Multi-center Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 396 (actual)
• Sponsor: Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.

Detailed description

Plasma aldosterone concentration and plasma renin activity / concentration measurement are important for early screening and diagnosis of Primary Aldosteronism (PA), most measurement methods are currently based on chemiluminescence, which may be cross-reactivity with other compounds and metabolites, leading to misdiagnosis or missed diagnosis of PA patients. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases. However, it is unknown for the cut-offs of PA screening and CCT test based on this technology in China. Therefore, the purpose of this study is to establish the screening and CCT cut-off point for primary aldosteronism based on LC-MS/MS technique at multicenter in China.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Captopril Challenge Test	Patients received 50 mg captopril orally in the morning after sitting or standing for at least two hours. PAC and PRC were measured using mass spectrometry two hours after administration of capopril.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-07-25
• Last updated: 2024-12-16

Locations

2 sites across 1 country: China