Primary Aldosteronism LC-MS/MS-specific Cutoffs

Study Overview
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Brief Summary
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Aims to evaluation the LC-MS/MS-specific cutoffs of PA screening and CCT test.

Detailed Description
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Plasma aldosterone concentration and plasma renin activity / concentration measurement are important for early screening and diagnosis of Primary Aldosteronism (PA), most measurement methods are currently based on chemiluminescence, which may be cross-reactivity with other compounds and metabolites, leading to misdiagnosis or missed diagnosis of PA patients. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has been introduced into the clinical routine analysis of steroid hormones due to its higher specificity and is increasingly used for the diagnosis of adrenal diseases. However, it is unknown for the cut-offs of PA screening and CCT test based on this technology in China. Therefore, the purpose of this study is to establish the screening and CCT cut-off point for primary aldosteronism based on LC-MS/MS technique at multicenter in China.

Official Title
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LC-MS/MS-specific Cutoffs for Screening and Confirmatory Testing of Primary Aldosteronism: A Multi-center Study

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Diagnostic Test: Captopril Challenge Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is between 18-75 years old. Hypertension patients with high risk factors for PA (meeting one of the following criteria): a.Persistent hypertension (> 150 / 100mmHg); b. Refractory hypertension (combined with 3 antihypertensive drugs and one used as a diuretic,Blood pressure is still greater than 140 / 90 mmHg or four antihypertensive drugs are needed to control blood pressure of less than 140 / 90 mmHg); c.Hypertension with adrenal accidental tumor; d.Hypertension is associated with hypokalaemia; Recent and stable use of antihypertensive drugs for more than 2 weeks, The drug types may include: β receptor blockers, CCB(calcium channel blockers), angiotension converting enzyme inhibitors(ACEi), Angiotensin Receptor Blocker(ARB), mineralocorticoid receptor antagonists(MRA), and other diuretics. Exclusion Criteria: a.Patients who are unwilling to participate and complete the study or refuse to sign a written informed consent for the study; b.Patients diagnosed with other secondary hypertension (such as renal hypertension, renal artery stenosis, pheochromocytoma, Cushing's syndrome, etc.); c. Combined with severe renal insufficiency eGFR <30 ml/min / 1.73 m2, Or patients with liver insufficiency OR liver failure (Alanine aminotransferase and / or aspartate aminotransferase increased 2.5 times above the upper limit of normal); d. Clinical assessment of a dressing change risk, Including: Heart failure (NYHA stage grade II or above), any one or more of the stroke, myocardial infarction, and unstable angina pectoris diagnosed within three months; e. Patients who are pregnant or who are currently being treated with sex hormones and glucocorticoids; f.incurable malignancy; g. Other reasons make it difficult to change or stop the drug to complete the diagnosis. Discontinuation criteria:Study discontinuation means that the clinical study has not yet been completed per protocol,Stop it all halfway through it. If major safety problems occur in the study, should be suspended in time; The sponsor requested the suspension of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Aldosteronism Group<br>Patients diagnosed with primary aldosteronism | Diagnostic Test: Captopril Challenge Test<br>* Patients received 50 mg captopril orally in the morning after sitting or standing for at least two hours. PAC and PRC were measured using mass spectrometry two hours after administration of capopril.<br>|
| Essential Hypertension Group<br>Patients diagnosed with essential hypertension | Diagnostic Test: Captopril Challenge Test<br>* Patients received 50 mg captopril orally in the morning after sitting or standing for at least two hours. PAC and PRC were measured using mass spectrometry two hours after administration of capopril.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a LC-MS/MS assay-specific cut-off point of screening without medication interfering for primary aldosteronism. | Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS.Plasma aldosterone concentration and plasma renin activity will be combined and reported as an ARR in pg·L/ml·mU. | At baseline without medication interfering. | 
| Establish a LC-MS/MS assay-specific cut-off point of CCT without medication interfering for primary aldosteronism. | Measure the plasma aldosterone concentration by LC-MS/MS. | 2 hours after the captopril challenge test without medication interfering. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a LC-MS/MS assay-specific cut-off point of screening with medication interfering for primary aldosteronism. | Measure the plasma aldosterone concentration and plasma renin activity by LC-MS/MS. Plasma aldosterone concentration and plasma renin activity will be combined and reported as an ARR in pg·L/ml·mU. | At baseline with medication interfering. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic, Multicenter study