AVS After 1mg DST to Determine Subtype in PA

Study Overview
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Brief Summary
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To compare the effect of different procedures of AVS(after 1mg DST or not) in determining the subtypes and long-term outcomes of PA

Detailed Description
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All paticipants will be randomly divided into 1mg DST group(Intervention group,n=43) and placebo group(Control group,n=43) and to determining the subtypes and to compare the long-term outcomes of patients with PA.

Official Title
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Adrenal Venous Sampling Under 1 mg Overnight Dexamethasone Suppression Test to Determine Subtype in Primary Aldosteronism，a Single Center, Randomized, Double Blended, Placebo Controlled Clinical Trail

Conditions
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Primary Aldosteronism

Intervention / Treatment
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* Drug: Dexamethasone 1 MG Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or above, male or female, with legal capacity; Patients who diagnosed as primary aldosteronism and willing to surgery Exclusion Criteria: Pregnant or lactating women Patients with a history of malignant tumors or complicated with severe heart disease, eGFR<30ml/min/1.73m2, severe anemia (Hb<60g/L), stroke or acute coronary syndrome within 3 months, severe liver disease Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH; PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVS after 1mg DST<br>Patients divided into AVS after 1mg DST group need to oral 1mg dexamethasone the night before AVS | Drug: Dexamethasone 1 MG Oral Tablet<br>* oral 1 mg dexamethasone at 23:00-24:00 the night before AVS<br>|
| Placebo Comparator: AVS after placebo<br>Patients divided into AVS after placebo group need to oral placebo the night before AVS | Drug: Placebo<br>* oral placebo at 23:00-24:00 the night before AVS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete biochemical remission | Compare the rate of complete biochemical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria. | 1year | 
| Complete clinical remission | Compare the rate of complete clinical remission between two groups. Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily defined doses of antihypertensive agents | The daily defined doses of antihypertensive agents of patients' blood pressure well controlled | 1 year | 
| Successful catheterization rate | Calculate the successful rate of catheterization. Successful catheterization was defined as SI≥2 without ACTH stimulation or SI≥3 with ACTH stimulation. | procedure | 
| Adverse events | Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism. | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary aldosteronism, adrenal venous sampling