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

Accuracy of 24-hour Urinary Aldosterone Testing in Diagnosing Primary Aldosteronism and Analysis of Drug Interference Factors

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Primary Aldosteronism
• Intervention / Treatment: Diagnostic test: 24-hour urinary aldosterone measurement

• Study Type: Observational
• Enrollment (Actual): 999

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • China Chongqing The third hospital affiliated to the Third Millitary Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We recruited hypertensive individuals who were hospitalized in the Department of Hypertension and Endocrinology of Daping Hospital from April 2022 to October 2024.

Group 1: 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 primary aldosteronism.

Group 2: Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary aldosteronism; Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism.	Diagnostic test: 24-hour urinary aldosterone measurement; Collect 24-hour urine sample from each participant and complete the detection of urinary aldosterone content.
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.	Diagnostic test: 24-hour urinary aldosterone measurement; Collect 24-hour urine sample from each participant and complete the detection of urinary aldosterone content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension.	This study will define the cut-off value of 24-hour urinary aldosterone for identifying patients with primary aldosteronism in hypertensive patients.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relationship between 24-hour urinary aldosterone and target organ damage in hypertension.	This study will gain futher insight in the association between different target organ damage and the urinary excretion of aldosterone. We will try to find out the reationship between urinary aldosterone and renal function indicators, including eGFR and Urinary microalbumin, and cardiac function indicators, including IVST and PWT.	2 years
Impacts of antihypertensive medications on 24-h urinary aldosterone levels	Antihypertensive drugs are usually stopped prior to diagnostic testing since they affect the physiological renin-angiotensin-aldosterone system. It is frequently unsafe and impractical to stop taking all conflicting antihypertensive drugs, especially in patients with severe hypertension. The impact of antihypertensive drugs on 24-hour urinary aldosterone, however, has not yet been documented. We tried to investigate how antihypertensive drugs affected 24-hour urine aldosterone levels in this investigation.	2 years

Collaborators and Investigators

• Sponsor: Zhiming Zhu
• Investigators: Study Chair: Zhiming Zhu, MD, Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism
• Other Study ID Numbers: The value of 24h UA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No