Primary AldosteronismNCT06236698
The Diagnostic Performance of 24-hour Urinary Aldosterone for Primary Aldosteronism
An observational study of Primary Aldosteronism and Hypertension, run by Zhiming Zhu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- 24-hour urinary aldosterone measurement
- How many people
- 999 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
China Chongqing The third hospital affiliated to the Third Millitary Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Accuracy of 24-hour Urinary Aldosterone Testing in Diagnosing Primary Aldosteronism and Analysis of Drug Interference Factors
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.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- 24-hour urinary aldosterone measurement
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour urinary aldosterone measurementDiagnostic test
Collect 24-hour urine sample from each participant and complete the detection of urinary aldosterone content.
| Study group | Role | What they receive |
|---|---|---|
| Essential hypertension | 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 PA. Receives: Diagnostic Test: 24-hour urinary aldosterone measurement | |
| Primary aldosteronism | Adult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism. Receives: Diagnostic Test: 24-hour urinary aldosterone measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 identifying patients with primary aldosteronism in hypertensive patients.
Measured: 2 years
Secondary outcomes (2)
Impacts of antihypertensive medications on 24-h urinary aldosterone levels
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Mar 2022
- Primary completion30 Mar 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhiming Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiming Zhu, Third Military Medical University
- Investigators
- Zhiming Zhu, MD, Study chair, Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236698
- Sponsor's protocol ID
- The value of 24h UA
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
You M, Li X, Zhao H, Bai Z, Liu Y, Zhou Q, Li Q, Yang R, Zhang H, He H, Zhu Z, Yan Z. Diagnostic performance of 24-hour urinary aldosterone for primary aldosteronism in patients with or without discontinuation of antihypertensive medications. Hypertens Res. 2025 Nov;48(11):2864-2875. doi: 10.1038/s41440-025-02375-w. Epub 2025 Sep 19.
PubMed 40973763
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of 24-hour Urinary Aldosterone Testing in Diagnosing Primary Aldosteronism and Analysis of Drug Interference Factors
- ClinicalTrials.gov ID
- NCT06236698
- Acronym / sponsor ID
- The value of 24h UA
- Conditions
- Primary Aldosteronism, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Zhiming ZhuUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential hypertension | – | Diagnostic Test: 24-hour urinary aldosterone measurementAdult patients meet the 2018 Chinese guidelines for prevention and treatment of hypertension for a diagnosis of essential hypertension but without other obvious features of PA. |
| Primary aldosteronism | – | Diagnostic Test: 24-hour urinary aldosterone measurementAdult patients meet the Endocrine Society Clinical Practice Guidelines for a diagnosis of primary aldosteronism. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour urinary aldosterone measurementCollect 24-hour urine sample from each participant and complete the detection of urinary aldosterone content. | Diagnostic test | Essential hypertension, Primary aldosteronism |
Primary outcome
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.
2 secondary outcomes
Impacts of antihypertensive medications on 24-h urinary aldosterone levels
Time frame: 2 years
The relationship between 24-hour urinary aldosterone and target organ damage in hypertension.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 40973763You M, Li X, Zhao H, Bai Z, Liu Y, Zhou Q, Li Q, Yang R, Zhang H, He H, Zhu Z, Yan Z. Diagnostic performance of 24-hour urinary aldosterone for primary aldosteronism in patients with or without discontinuation of antihypertensive medications. Hypertens Res. 2025 Nov;48(11):2864-2875. doi: 10.1038/s41440-025-02375-w. Epub 2025 Sep 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiming Zhu, MD study chair
Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Hypertension, run by Zhiming Zhu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cut-off value of 24-hour urinary aldosterone for distinguishing primary aldosteronism from primary hypertension. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.