The Predictive Value of 24-hour Urinary Aldosterone on Target Organ Damage

Recruiting

• Conditions: Primary Aldosteronism; Hypertension
• Interventions: Diagnostic Test: 24-hour urinary aldosterone

• Registration Number: NCT06236698
• Lead Sponsor: Third Military Medical University

Brief Summary

This is an observational study to define the cut-off value of 24-hour urinary aldosterone for screening 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-20
• Status Verified: 2024-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-02-28
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Aged 18 years and above.
2. Meets the ACC/AHA hypertension guidelines for a diagnosis of hypertension with an age of onset of hypertension between 18-60 years.
3. Meets the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism with an age of onset of hypertension between 18-60 years.

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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 < 30 mL/min.
4. IgA nephropathy.
5. Alcohol abuse or pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Essential hypertension	24-hour urinary aldosterone	Adult patients meet the ACC/AHA hypertension guidelines for a diagnosis of essential hypertension but without other obvious features of PA.
Primary aldosteronism	24-hour urinary aldosterone	Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism.

Primary Outcome Measures

Name	Time	Method
The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension.	2 years	This study will define the cut-off value of 24-hour urinary aldosterone for screening primary aldosteronism in hypertensive patients based on chemiLuminescence. Moreover, 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.
The relationship between 24-hour urinary aldosterone and target organ damage in hypertension.	2 years	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.

Trial Locations

Locations (1)

China Chongqing The third hospital affiliated to the Third Millitary Medical University; 🇨🇳 Chongqing, Chongqing, China