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
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Captopril inhibition test(CCT).
- Who it may be relevant to
- Registry conditions: Primary Aldosteronism. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 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-ho
Primary outcome measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical Colledge Hospital — Beijing
Identifiers
NCT: NCT07691801 · pumch-06086-11