RecruitingNCT07691801

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

Sponsor

Peking Union Medical College Hospital

Enrollment

800 participants

Start Date

Apr 28, 2025

Study Type

OBSERVATIONAL

Conditions

Primary Aldosteronism

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria12

Normal Control Group
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
Patients with suspected primary aldosteronism in the outpatient setting
Willing to undergo 4-week spironolactone treatment and cooperate with follow-up

Exclusion Criteria15

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
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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Interventions

DIAGNOSTIC_TESTCaptopril 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.