Study on the Diagnostic Cut-off Point of 24-hour Urinary Aldosterone Measured by Liquid Chromatography-Tandem Mass Spectrometry in the Diagnosis of Primary Aldosteronism in the Oral Sodium Loading Test

NCT07635134 | Recruiting DMC

• 1 other identifier: pumch-06086-10
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography - tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay in measuring aldosterone. This study aims to establish a more precise diagnostic threshold for the oral sodium loading test (OSLT) by using LC-MS/MS to measure urinary aldosterone levels. We will combine the biochemical results of OSLT and other data from healthy volunteers and suspected PA patients to determine a new 24-hour urinary aldosterone threshold. We expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.

Conditions

Primary Aldosteronism

Keywords

the oral sodium loading test; diagnose

Outcome Measures

Primary Outcomes (1)

• 24-hour urinary aldosterone levels after a 3-day high-sodium diet

  Two weeks after completing the oral sodium loading test

Study Arms (2)

normal sujects

Healthy volunteers with normal blood pressure and blood potassium levels and no adrenal nodules. These volunteers were used to determine the normal physiological range (lower limit value) of aldosterone inhibition after the test.

Diagnostic Test: The oral sodium loading test

Patients suspected of having primary aldosteronism

Patients suspected of having primary aldosteronism

Diagnostic Test: The oral sodium loading test

Interventions

The oral sodium loading test DIAGNOSTIC_TEST

These subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day. On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile.

Patients suspected of having primary aldosteronism; normal sujects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1）Healthy Controls to establish physiological suppression limits.2) Patients with suspected PA undergo oral sodium loading test to determine the cut-off point.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical Colledge Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism; Disease

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tong Anli

CONTACT

+8613460884085; tonganli@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)