Clinical trial NCT06236698: The Diagnostic Performance of 24-hour Urinary Aldosterone for Primary Aldosteronism
Official title: Accuracy of 24-hour Urinary Aldosterone Testing in Diagnosing Primary Aldosteronism and Analysis of Drug Interference Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Hypertension
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension.
timeFrame: 2 years
Secondary outcomes:
measure: Impacts of antihypertensive medications on 24-h urinary aldosterone levels
timeFrame: 2 years
measure: The relationship between 24-hour urinary aldosterone and target organ damage in hypertension.
timeFrame: 2 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: China Chongqing The third hospital affiliated to the Third Millitary Medical University
state: Chongqing
Study officials:
affiliation: Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University
name: Zhiming Zhu, MD
role: STUDY_CHAIR
References: