Simplification of Oral Sodium Loading Test in the Diagnosis of Primary Aldosteronism: 2-day Replacing 3-day Method

Recruiting

• Conditions: Primary Aldosteronism

• Registration Number: NCT06750172
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

To compare the consistency of 24-hour urinary aldosterone in the diagnosis of primary aldosteronism by oral sodium loading test between the second day method and the third day method

Detailed Description

This is an exploratory and prospective study of 17 healthy controls and 15 patients with primary aldosteronism, in which each participant will receive a high-sodium diet for 3 days to conduct a confirmatory test for primary aldosteronism. The consistency between the 2-day and 3-day oral sodium loading test for the diagnosis of primary aldosteronism is compared by measuring the 24-hour urinary aldosterone levels of the participants on the second and third days of the high-sodium diet. The study aims to explore whether the 24-hour urinary aldosterone level on the second day can replace the 24-hour urinary aldosterone level on the third day for the diagnosis of primary aldosteronism.

Study Timeline

• Study Start: 2023-12-15
• Status Verified: 2024-11
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Primary Completion: 2024-12-25
• Study Completion: 2024-12-25
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consistency of 2-day and 3-day 24h urinary aldosterone in the oral sodium load test	4 day	To explore whether there was statistical difference in the 24h urinary aldosterone on the 2nd day and the 3rd day detected by LC-MS (Liquid chromatography-tandem mass spectrometry) in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism

Secondary Outcome Measures

Name	Time	Method
consistency of the the aldosterone-to-renin ratio(ARR) on the second day and the third day in oral sodium load test	4 day	To explore whether there was statistical difference in the aldosterone-to-renin ratio on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism
Consistency of 2-day and 3-day PAC(Plasma aldosterone concentration) in the oral sodium load test	4 day	To explore whether there was statistical difference in plasma aldosterone concentration on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism.
Consistency of the plasma renin activity on the second day and the third day in oral sodium load test	4 day	To explore whether there was statistical difference in the plasma renin activity on the second day and the third day in oral sodium load test, and to study whether the 2-day method can replace the 3-day method in the diagnosis of primary aldosteronism

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China