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

Zhiming Zhu

Status: Completed

Conditions: Hypertension; Primary Aldosteronism

Treatments: Diagnostic Test: 24-hour urinary aldosterone measurement

Study type: Observational

Funder types: Other

Identifiers

NCT06236698

The value of 24h UA

Details and patient eligibility

About

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.

Enrollment: 999 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

999 participants in 2 patient groups

Essential hypertension

Description:

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.

Treatment:

Diagnostic Test: 24-hour urinary aldosterone measurement

Primary aldosteronism

Description:

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

Treatment:

Diagnostic Test: 24-hour urinary aldosterone measurement