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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 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2026-06-09

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

The oral sodium loading 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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-07-01
Completion
2026-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635134 on ClinicalTrials.gov