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Completed

NCT Number: NCT06236698

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

24-hour urinary aldosterone measurement

Diagnostic Test

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

Primary outcomes

  1. The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension.

    Time frame: 2 years

    This study will define the cut-off value of 24-hour urinary aldosterone for identifying patients with primary aldosteronism in hypertensive patients.

Secondary outcomes

  1. Impacts of antihypertensive medications on 24-h urinary aldosterone levels

    Time frame: 2 years

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhiming Zhu

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 1, 2024
Registry last updated
Apr 16, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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