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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: normal sujects1 intervention
Group B: Patients suspected of having primary aldosteronism1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Two weeks after completing the oral sodium loading test

Secondary outcomes

Other outcomes

Sponsors and contacts

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