This study is a prospective, multicenter, randomized clinical trial aimed to compare the impact of three AVS diagnostic strategies on the clinical outcomes of patients with primary aldosteronism. The strategies include sequential combined AVS (non-ACTH-stimulated followed by ACTH-stimulated AVS), non- ACTH-stimulated AVS alone, and ACTH-stimulated AVS alone. The findings of this study will provide critical evidence for the clinical practice standards of AVS.
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Diagnosed with primary aldosteronism. # Age 18-70 years with hypertension, any sex.
Patients for whom AVS can be bypassed: Typical BPA (normal serum potassium and plasma aldosterone concentration (PAC) < 110 pg/mL, eligible for direct medical therapy); Typical UPA (PAC ≥ 200 pg/mL, plasma renin concentration (PRC) ≤ 5 μIU/mL, spontaneous hypokalemia, unilateral adrenal adenoma ≥ 1 cm with normal contralateral adrenal on CT or 68Ga-Pentixafor PET-CT indicating unilateral functional tumor, eligible for direct surgery);
Refusal of AVS or surgery, or contraindication to surgery.
Allergy to ACTH or contrast agents.
Combined with autonomous cortisol secretion (1 mg overnight dexamethasone suppression test cortisol ≥ 50 nmol/L).
Parallel
sequential combined AVS
Diagnostic testnon-ACTH-stimulated followed by ACTH-stimulated AVS
The proportion of complete biochemical remission
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.
The proportion of complete clinical remission
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 clinical remission according to PASO consensus criteria.
The proportion of complete biochemical response rate
Blood was drawn to measure aldosterone, renin and potassium.According to PAMO criteria, outcomes of medication for bilateral primary aldosteronism were classified into complete, partial, and absent response, for both clinical and biochemical outcomes.The proportion of complete biochemical response according to PAMO consensus criteria.
The proportion of complete clinical response rate
Blood was drawn to measure aldosterone, renin and potassium.According to PAMO criteria, outcomes of medication for bilateral primary aldosteronism were classified into complete, partial, and absent response, for both clinical and biochemical outcomes.The proportion of complete clinical response according to PAMO consensus criteria.
Comparison of adverse events
The occurrence of adverse events was recorded, including adrenal vein rupture, peripheral puncture site complications including femoral vein thrombosis, puncture site hematoma, ACTH allergy, and anaphylactic shock., etc.
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Shumin Yang
Lead sponsor
Chongqing Medical University
Sponsor institution
First Affiliated Hospital of Kunming Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
The People's Hospital of Chuxiong Yi Autonomous Prefecture
Collaborator
