Primary AldosteronismNCT07691801
Study on the Application of Liquid Chromatography-Tandem Mass Spectrometry for the Determination of Aldosterone and Renin Activity in the Diagnosis of Primary Aldosteronism by Captopril 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 method 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?
- Captopril inhibition test(CCT)
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 28 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 captopril inhibition test to determine the cut-off point.
Who may be able to join
- Age 18-70 years old
- BMI: 18.5-23.9kg/m²
- Gender not restricted
- Blood pressure: 100-120/60-80mmHg
- No history of hypertension
- No abnormal nodules found in adrenal CT
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- Previous blood potassium and electrocardiogram were all within normal ranges
- No history of liver or kidney dysfunction, malignant tumors, metabolic diseases or cardiovascular diseases
- No medication used
- Patients with suspected primary aldosteronism in the outpatient setting
- Willing to undergo 4-week spironolactone treatment and cooperate with follow-up
Who cannot join
- 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
- Patients who did not complete the captopril suppression test
- Patients with Cushing's syndrome or other endocrine tumors
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- 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, 456350
Li zewen, +8613460884085, 13460884085@163.com
13460884085@163.com
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 method in measuring aldosterone. This study aims to establish a more precise diagnostic cutoff value for the captopril stimulation test (CCT) by measuring aldosterone levels using LC-MS/MS. The investigators will combine the detection results of CCT from healthy volunteers and suspected PA patients, etc., to determine the new CCT cutoff value. The investigators 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
- Captopril inhibition test(CCT)
- Keywords
- diagnose, Captopril Inhibition Test (CCT)
- Medical subject headings
- Hyperaldosteronism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Captopril inhibition test(CCT)Diagnostic test
The subjects are required to stop using any drugs that affect the RAAS system in advance. At 08:00 on the test day, they are to remain seated and collect baseline blood samples. Then, they are to take 25mg of captopril orally. After taking the medicine, they are to remain seated and fast for 2 hours, and then collect blood samples again at 10:00. The blood samples collected at these two time points will undergo mass spectrometry analysis to detect plasma aldosterone and renin activity, and 24-hour urine samples will be collected to measure 24-hour urine sodium and 24-hour urine potassium.
| Study group | Role | What they receive |
|---|---|---|
| normal sujects | Healthy volunteers with normal blood pressure, normal blood potassium levels, and no adrenal nodules. These individuals were used to establish the normal physiological range (lower limit) of aldosterone suppression after the test. Receives: Diagnostic Test: Captopril inhibition test(CCT) | |
| Patients suspected of having primary aldosteronism | Patients suspected of having primary aldosteronism Receives: Diagnostic Test: Captopril inhibition test(CCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test
Measured: Two weeks after completing the captopril inhibition test
Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition test
Measured: Two weeks after completing the captopril inhibition test
Aldosterone-renin ratio（ARR）by LC-MS/MS before and after captopril inhibition test
Measured: Two weeks after completing the captopril inhibition test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start28 Apr 2025
- Primary completion1 Aug 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
- NCT07691801
- Sponsor's protocol ID
- pumch-06086-11
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application of Liquid Chromatography-Tandem Mass Spectrometry for the Determination of Aldosterone and Renin Activity in the Diagnosis of Primary Aldosteronism by Captopril Test
- ClinicalTrials.gov ID
- NCT07691801
- Acronym / sponsor ID
- pumch-06086-11
- Conditions
- Primary Aldosteronism
- Keywords
- diagnose, Captopril Inhibition Test (CCT)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 9 Jul 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 method in measuring aldosterone. This study aims to establish a more precise diagnostic cutoff value for the captopril stimulation test (CCT) by measuring aldosterone levels using LC-MS/MS. The investigators will combine the detection results of CCT from healthy volunteers and suspected PA patients, etc., to determine the new CCT cutoff value. The investigators 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: Captopril inhibition test(CCT)Healthy volunteers with normal blood pressure, normal blood potassium levels, and no adrenal nodules. These individuals were used to establish the normal physiological range (lower limit) of aldosterone suppression after the test. |
| Patients suspected of having primary aldosteronism | – | Diagnostic Test: Captopril inhibition test(CCT)Patients 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 captopril inhibition test to determine the cut-off point.
Key inclusion criteria (11 listed)
- Age 18-70 years old
- BMI: 18.5-23.9kg/m²
- Gender not restricted
- Blood pressure: 100-120/60-80mmHg
- No history of hypertension
Key exclusion criteria (15 listed)
- 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
- Patients who did not complete the captopril suppression test
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 |
|---|---|---|
| Captopril inhibition test(CCT)The subjects are required to stop using any drugs that affect the RAAS system in advance. At 08:00 on the test day, they are to remain seated and collect baseline blood samples. Then, they are to take 25mg of captopril orally. After taking the medicine, they are to remain seated and fast for 2 hours, and then collect blood samples again at 10:00. The blood samples collected at these two time points will undergo mass spectrometry analysis to detect plasma aldosterone and renin activity, and 24-hour urine samples will be collected to measure 24-hour urine sodium and 24-hour urine potassium. | Diagnostic test | Patients suspected of having primary aldosteronism, normal sujects |
Primary outcome
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test
Time frame: Two weeks after completing the captopril inhibition test
Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition test
Time frame: Two weeks after completing the captopril inhibition test
Aldosterone-renin ratio（ARR）by LC-MS/MS before and after captopril inhibition test
Time frame: Two weeks after completing the captopril inhibition 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 Jul 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?
The sponsor lists 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 9 Jul 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?
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test (time frame: Two weeks after completing the captopril inhibition test). The study lists 3 primary outcomes in all. 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 Jul 2026.