Captopril Test with LC-MS/MS for Aldosterone and Renin in Primary Aldosteronism
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
Run by Peking Union Medical College Hospital · NCT07691801 · Data updated 2026-11-12
This study tests whether measuring aldosterone with LC-MS/MS during a captopril test can better diagnose primary aldosteronism.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | April 28, 2025 |
| Main results expected | August 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07691801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 without prior hypertension or with suspected primary aldosteronism, including those willing to undergo spironolactone treatment for PA evaluation.
✕Probably not a fit
Individuals without primary aldosteronism or whose condition is not detectable by this testing approach may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares aldosterone measurements by LC-MS/MS to conventional methods during the captopril inhibition test to establish a more precise diagnostic cutoff for primary aldosteronism. It will include healthy volunteers and patients suspected of PA to determine an improved threshold. The goal is to improve diagnostic accuracy and help clinicians identify and treat PA earlier. The study uses a standardized captopril test protocol and analyzes aldosterone and renin activity to refine the diagnostic criteria.
Why it matters
Potential benefit: If successful, clinicians could diagnose primary aldosteronism more accurately using a LC-MS/MS-based cutoff, enabling earlier and more targeted treatment.
How similar studies have gone: Previous methods using LC-MS/MS for aldosterone measurement have shown improved accuracy over radioimmunoassay, but the specific cutoff via CCT with LC-MS/MS is being refined in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Normal Control Group Inclusion Criteria * 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 * 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 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 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 captopril suppression 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
Where it's running
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Peking Union Medical Colledge Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Tong Anli
- Email: tonganli@hotmail.com
- Phone: +8613460884085
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.