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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Primary aldosteronism | Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-hour urinary aldosterone measurement | Diagnostic Test | Collect 24-hour urine sample from each participant and complete the detection of urinary aldosterone content. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Zhiming Zhu, MD | Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Chongqing The third hospital affiliated to the Third Millitary Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40973763 | Derived | You M, Li X, Zhao H, Bai Z, Liu Y, Zhou Q, Li Q, Yang R, Zhang H, He H, Zhu Z, Yan Z. Diagnostic performance of 24-hour urinary aldosterone for primary aldosteronism in patients with or without discontinuation of antihypertensive medications. Hypertens Res. 2025 Nov;48(11):2864-2875. doi: 10.1038/s41440-025-02375-w. Epub 2025 Sep 19. |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
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| 2 years |
| 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 |
| D002318 | Cardiovascular Diseases |