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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
normal sujects
Healthy volunteers with normal blood pressure, normal blood potassium levels, and no adrenal nodules. These individuals were used to establish the normal physiological range (lower limit) of aldosterone suppression after the test.
干预措施: Captopril inhibition test(CCT) (Diagnostic Test)
Patients suspected of having primary aldosteronism
Patients suspected of having primary aldosteronism
干预措施: Captopril inhibition test(CCT) (Diagnostic Test)
结局指标
主要结局
Plasma Aldosterone Concentration (PAC) by LC-MS/MS before and after captopril inhibition test
时间窗: Two weeks after completing the captopril inhibition test
Plasma Renin activity(PRA) by LC-MS/MS before and after captopril inhibition test
时间窗: Two weeks after completing the captopril inhibition test
Aldosterone-renin ratio（ARR）by LC-MS/MS before and after captopril inhibition test
时间窗: Two weeks after completing the captopril inhibition test
次要结局
未报告次要终点