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

NCT ID: NCT06236698

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 999 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-10-30

Brief 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

Primary Aldosteronism; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Essential hypertension

Adult patients meet the 2018 Chinese guidelines for prevention and treatment of hypertension for a diagnosis of essential hypertension but without other obvious features of PA.

24-hour urinary aldosterone measurement

Intervention Type: DIAGNOSTIC_TEST

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

Primary aldosteronism

Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism.

24-hour urinary aldosterone measurement

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

24-hour urinary aldosterone measurement

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years and above.

2. Meets the 2018 Chinese guidelines for prevention and treatment of hypertension for a diagnosis of hypertension with an age of onset of hypertension between 18-80 years.

3. Meets the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism with an age of onset of hypertension between 18-80 years.

Exclusion Criteria

1. Other causes of secondary hypertension, including renal hypertension, renovascular hypertension and adrenal hypertension (i.e., pheochromocytoma and Cushing syndrome).

2. Urine output less than 400ml per day.

3. Severe renal insufficiency with a glomerular filtration rate < 60 mL/min/1.73 m2.

4. lack of 24-h urinary aldosterone data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhiming Zhu

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhiming Zhu, MD

Role: STUDY_CHAIR

Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University

Locations

China Chongqing The third hospital affiliated to the Third Millitary Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

The value of 24h UA

Identifier Type: -

Identifier Source: org_study_id