Primary AldosteronismNCT07635134
Study on the Diagnostic Cut-off Point of 24-hour Urinary Aldosterone Measured by Liquid Chromatography-Tandem Mass Spectrometry in the Diagnosis of Primary Aldosteronism in the Oral Sodium Loading Test
An observational study of Primary Aldosteronism, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography - tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay in measuring aldosterone. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- The oral sodium loading test
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Aug 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1）Healthy Controls to establish physiological suppression limits.2) Patients with suspected PA undergo oral sodium loading test to determine the cut-off point.
Inclusion criteria for the normal control group: Age 18-70 years old, BMI: 18.5-23.9kg/m ²，gender not restricted. blood pressure: 100-120/60-80mmHg. no history of hypertension. No abnormal nodules found in adrenal CT. Previous blood potassium and electrocardiogram were all within normal ranges., No history of liver or kidney dysfunction, malignant tumors, metabolic diseases or cardiovascular diseases, and no medication used.
Exclusion criteria: Those with a family history of hypertension or with clinical manifestations of secondary hypertension. Those who have been taking drugs that may affect the RAAS system for a long time (such as contraceptives, steroids, etc.). Those with cardiac dysfunction or severe arrhythmia and unable to tolerate the test.
Patients with suspected primary aldosteronism in the outpatient setting. Inclusion criteria: Patients with suspected primary aldosteronism in the outpatient setting. Willing to undergo 4-week spironolactone treatment and cooperate with follow-up.
Exclusion criteria: Patients who did not complete the oral sodium loading test. Patients with Cushing's syndrome or other endocrine tumors. Patients allergic to spironolactone or with contraindications for its use (such as severe hyperkalemia, eGFR < 30).History of liver or kidney dysfunction, coexisting severe cardiovascular or cerebrovascular diseases, history of malignant tumors, other types of endocrine hypertension (hyperthyroidism, pheochromocytoma, Cushing's syndrome, etc.), renal artery stenosis, hypokalemia caused by other factors (renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc.), diabetes with HbA1c > 7.0% or currently using or having used insulin or SGLT2 inhibitor drugs, taking special medications such as glucocorticoids, immunosuppressants, oral contraceptives, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical Colledge Hospital
Beijing, Beijing Municipality, 100000
Li Zewen, b2023001041@pumc.edu.cn
About this study
Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography - tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay in measuring aldosterone. This study aims to establish a more precise diagnostic threshold for the oral sodium loading test (OSLT) by using LC-MS/MS to measure urinary aldosterone levels. We will combine the biochemical results of OSLT and other data from healthy volunteers and suspected PA patients to determine a new 24-hour urinary aldosterone threshold. We expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.
- Conditions
- Primary Aldosteronism
- Being tested
- The oral sodium loading test
- Keywords
- the oral sodium loading test, diagnose
- Medical subject headings
- Hyperaldosteronism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The oral sodium loading testDiagnostic test
These subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day. On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile.
| Study group | Role | What they receive |
|---|---|---|
| normal sujects | Healthy volunteers with normal blood pressure and blood potassium levels and no adrenal nodules. These volunteers were used to determine the normal physiological range (lower limit value) of aldosterone inhibition after the test. Receives: Diagnostic Test: The oral sodium loading test | |
| Patients suspected of having primary aldosteronism | Patients suspected of having primary aldosteronism Receives: Diagnostic Test: The oral sodium loading test |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary aldosterone levels after a 3-day high-sodium diet
Measured: Two weeks after completing the oral sodium loading test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Apr 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635134
- Sponsor's protocol ID
- pumch-06086-10
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Diagnostic Cut-off Point of 24-hour Urinary Aldosterone Measured by Liquid Chromatography-Tandem Mass Spectrometry in the Diagnosis of Primary Aldosteronism in the Oral Sodium Loading Test
- ClinicalTrials.gov ID
- NCT07635134
- Acronym / sponsor ID
- pumch-06086-10
- Conditions
- Primary Aldosteronism
- Keywords
- the oral sodium loading test, diagnose
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Jun 2026 (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.
Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography - tandem mass spectrometry (LC-MS/MS) is more accurate than the traditional radioimmunoassay in measuring aldosterone. This study aims to establish a more precise diagnostic threshold for the oral sodium loading test (OSLT) by using LC-MS/MS to measure urinary aldosterone levels. We will combine the biochemical results of OSLT and other data from healthy volunteers and suspected PA patients to determine a new 24-hour urinary aldosterone threshold. We expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal sujects | – | Diagnostic Test: The oral sodium loading testHealthy volunteers with normal blood pressure and blood potassium levels and no adrenal nodules. These volunteers were used to determine the normal physiological range (lower limit value) of aldosterone inhibition after the test. |
| Patients suspected of having primary aldosteronism | – | Diagnostic Test: The oral sodium loading testPatients suspected of having primary aldosteronism |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1）Healthy Controls to establish physiological suppression limits.2) Patients with suspected PA undergo oral sodium loading test to determine the cut-off point.
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 |
|---|---|---|
| The oral sodium loading testThese subjects underwent a three-day high-salt diet test, during which they consumed an additional 6-10 grams of salt each day. On the third day, tests were conducted on the aldosterone, sodium, potassium and creatinine levels in the 24-hour urine, blood potassium, creatinine, standing aldosterone concentration, plasma renin activity, and the steroid hormone profile. | Diagnostic test | Patients suspected of having primary aldosteronism, normal sujects |
Primary outcome
24-hour urinary aldosterone levels after a 3-day high-sodium diet
Time frame: Two weeks after completing the oral sodium loading test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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, run by Peking Union Medical College Hospital 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?
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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tong Anli (+8613460884085, tonganli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urinary aldosterone levels after a 3-day high-sodium diet (time frame: Two weeks after completing the oral sodium loading test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.