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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Primary Aldosteronism
• Intervention / Treatment: Diagnostic test: 24-hour urinary aldosterone

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Zhencheng Yan, MD; Phone Number: +8613983656682; Email: zhenchengyan@sina.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • Recruiting
      • China Chongqing The third hospital affiliated to the Third Millitary Medical University
      • Contact: Zhencheng Yan, MD; Phone Number: 86-023-68757882; Email: zhenchengyan@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: 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 December 2023.

Group 1: Adult patients meet the ACC/AHA hypertension guidelines 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.

Description

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.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Essential hypertension; Adult patients meet the ACC/AHA hypertension guidelines for a diagnosis of essential hypertension but without other obvious features of PA.	Diagnostic test: 24-hour urinary aldosterone; Collect 24-hour urine from each participant and complete the detection of urinary aldosterone content.
Primary aldosteronism; Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism.	Diagnostic test: 24-hour urinary aldosterone; Collect 24-hour urine from each participant and complete the detection of urinary aldosterone content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 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.	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

Collaborators and Investigators

• Sponsor: Third Military Medical University
• Investigators: Study Chair: Zhiming Zhu, MD, Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: The value of 24h UA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No