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

NCT06236698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 999

Last updated 2025-04-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

24-hour urinary aldosterone measurement

Collect 24-hour urine sample from each participant and complete the detection of urinary aldosterone content.

Sponsors & Collaborators

  • Zhiming Zhu

    lead OTHER

Principal Investigators

  • Zhiming Zhu, MD · Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-03-30
Completion
2024-10-30

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT06236698 on ClinicalTrials.gov