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NCT06236698

The Diagnostic Performance of 24-hour Urinary Aldosterone for Primary Aldosteronism

Completed Last updated 16 April 2025
What this trial tests

trial testing 24-hour urinary aldosterone measurement in Primary Aldosteronism in 999 participants. Completed in 30 October 2024.

Timeline
1 March 2022
Primary endpoint
30 March 2024
30 October 2024

Quick facts

Lead sponsorZhiming Zhu
StatusCompleted
Study typeOBSERVATIONAL
Enrollment999
Start date1 March 2022
Primary completion30 March 2024
Estimated completion30 October 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Zhiming Zhu — full company profile →

Who can join

Adults 18 to 80, any sex, with Primary Aldosteronism or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an observational study to define the cut-off value of 24-hour urinary aldosterone for diagnosing primary aldosteronism in hypertensive patients in our center. Plasma aldosterone and renin measurements are subject to significant intra-individual variability, including variation related to posture, time of day and sodium balance. Aldosterone secretion is not constant and may be subject to diurnal variation. As such one-off testing of ARR, does not consider the salt status of the individual necessitating repetition of tests to ensure false negative or false positive test results are ruled out. The value of accumulated aldosterone in a 24-hour sample has the advantage that it does not depend on circadian variation. This study will help establish the positivity rates of 24-hour urine aldosterone, and test the robustness of current standard guidelines for primary aldosteronism screening and case confirmation. Previous studies reported that primary aldosteronism is associated with a higher risk of CV complications and a higher prevalence of target organ damage. Also, previous studies reported on the association of echocardiographic parameters with circulating or urinary aldosterone. Therefore, we intent to investigate the independent associations of different target organ damage with the urinary excretion of aldosterone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Primary Aldosteronism

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