NCT06236698Completed
The Diagnostic Performance of 24-hour Urinary Aldosterone for Primary Aldosteronism
Accuracy of 24-hour Urinary Aldosterone Testing in Diagnosing Primary Aldosteronism and Analysis of Drug Interference Factors
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 999 (actual)
- First submitted
- 24 Jan 2024
- Start date
- 1 Mar 2022
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- Zhiming Zhu
- Diseases
- High blood pressure
- NCT number
- NCT06236698
What you commit to
- Study type: Observational
- Participants enrolled: 999
- From 1 Mar 2022 to the primary completion date, 30 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other causes of secondary hypertension, including renal hypertension, renovascular hypertension and adrenal hypertension (i.e., pheochromocytoma and Cushing syndrome).
- Severe renal insufficiency with a glomerular filtration rate \< 60 mL/min/1.73 m2.
Other
- Urine output less than 400ml per day.
- lack of 24-h urinary aldosterone data.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Chongqing The third hospital affiliated to the Third Millitary Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.