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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236698
• Other study ID #: The value of 24h UA
• Status: Recruiting
• Start date: May 20, 2022
• Est. completion date: May 30, 2024

Study information

• Verified date: January 2024
• Source: Third Military Medical University
• Contact: Zhencheng Yan, MD
• Phone: +8613983656682
• Email: zhenchengyan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism

Intervention

Diagnostic Test:
• 24-hour urinary aldosterone
Collect 24-hour urine from each participant and complete the detection of urinary aldosterone content.

Locations

Country	Name	City	State
China	China Chongqing The third hospital affiliated to the Third Millitary Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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