AVS After 1mg DST to Determine Subtype in PA

Shanghai Zhongshan Hospital110 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

110

Conditions

Primary Aldosteronism

Interventions

Dexamethasone 1 MG Oral TabletDRUG

oral 1 mg dexamethasone at 23:00-24:00 the night before AVS

PlaceboDRUG

oral placebo at 23:00-24:00 the night before AVS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 or above, male or female, with legal capacity; 2. Patients who diagnosed as primary aldosteronism and willing to surgery Exclusion Criteria: 1. Pregnant or lactating women 2. 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 3. Having contraindications or refusal to undergo AVS or unilateral adrenalectomy, or allergy to ACTH; 4. PA combined with Cushing syndrome (including subclinical Cushing); or considering glucocorticoid-suppressible aldosteronism (GRA) or adrenocortical carcinoma;

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 year

Secondary Outcomes

Daily defined doses of antihypertensive agents

The daily defined doses of antihypertensive agents of patients' blood pressure well controlled

Time frame: 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.

Time frame: procedure

Adverse events

Including adrenal venous hemorrhage and related adrenal insufficiency, hypertensive urgencies, anaphylactic shock, venous thrombosis, pulmonary embolism.

Time frame: 3 month

Data from ClinicalTrials.gov

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