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

NCT06236698 | Completed

• 1 other identifier: The value of 24h UA
• Study Type: observational
• Target: 999
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impacts of antihypertensive medications on 24-h urinary aldosterone levels

  2 years

• The relationship between 24-hour urinary aldosterone and target organ damage in hypertension.

  2 years

Study Arms (2)

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

Primary aldosteronism

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

Diagnostic Test: 24-hour urinary aldosterone measurement

Interventions

24-hour urinary aldosterone measurement DIAGNOSTIC_TEST

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

Essential hypertension; Primary aldosteronism

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Other causes of secondary hypertension, including renal hypertension, renovascular hypertension and adrenal hypertension (i.e., pheochromocytoma and Cushing syndrome).
• Urine output less than 400ml per day.
• Severe renal insufficiency with a glomerular filtration rate \< 60 mL/min/1.73 m2.
• lack of 24-h urinary aldosterone data.

Sponsors & Collaborators

• Zhiming Zhu: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhiming Zhu, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: March 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: October 30, 2024
• Last Updated: April 16, 2025

Record last verified: 2025-03

Locations

CN (1)