NCT07691801 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
| NCT ID | NCT07691801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Primary Aldosteronism |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-04-28 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07691801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07691801 currently recruiting?
Yes, NCT07691801 is actively recruiting participants. Contact the research team at tonganli@hotmail.com for enrollment information.
Where is the NCT07691801 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07691801 clinical trial?
NCT07691801 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 800 participants.