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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

Recruitingn/aAges 18 Years - 70 YearsAllPeking Union Medical College Hospital
NCT07691801 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Captopril inhibition test(CCT)
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Where

1 site
Peking Union Medical Colledge Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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