Idiopathic hyperaldosteronism (IHA) represents about 65% of primary hyperaldosteronism cases. Although mineralocorticoid receptor antagonists (MRAs) are the standard first-line treatment, they are often limited by adverse effects. Superselective adrenal artery embolization (SAAE) has been utilized for IHA over the last decade, yet comparative studies against MRAs are lacking. The objective of this study is to compare the safety and efficacy of SAAE and MRA to determine the feasibility of SAAE in treating IHA.
Aged from 15 to 60 with no limits in sex;
Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
Patients or their legal representatives have to sign written informed consent approved by the ethics committee.
Unilateral adrenal hyperplasia;
Renal insufficiency with an estimated glomerular filtration rate (based on the modification of diet in renal disease criteria) <45 ml/min/1.73 m², and/or serum creatinine >176 μmol/L；
Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
Severe contrast agent allergy;
Parallel
Superselective Adrenal Arterial Embolization
Procedure/SurgeryPatients in this group will undergo percutaneous superselective adrenal artery embolization (SAAE). Under fluoroscopic guidance, a microcatheter or an over-the-wire balloon catheter will be navigated into the target adrenal arteries, followed by the slow, controlled infusion of absolute ethanol to achieve localized tissue ablation.
Spironolactone
DrugPatients will be treated with spironolactone.
Change of 24-h mean systolic blood pressure at 6 months compared with baseline.
change of 24-h mean systolic blood pressure at 6 months compared with baseline.
Change of 24-h mean diastolic blood pressure at 6 months compared with baseline.
change of 24-h mean diastolic blood pressure at 6 months compared with baseline.
Change of office systolic and diastolic blood pressure at 1, 3, 6 months, 24-h mean systolic and diastolic blood pressure at 1, 3 months, compared with baseline
Change of office blood pressure at 1, 3, 6 months compared with baseline
change of antihypertensive medication burden at 1, 3, 6 months compared with baseline
change of antihypertensive medication burden at 6 months compared with baseline
Incidence of clinical events
Incidence of clinical events including: major adverse cardiovascular events(MACE), renal insufficiency, adrenal insufficiency, hyperkalemia, vascular complication, flank/back pain, gynecomastia, breast tenderness, sexual dysfunction,etc.
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Chinese Academy of Medical Sciences, Fuwai Hospital
Lead sponsor
Second Affiliated Hospital of Nanchang University
Collaborator
First Affiliated Hospital of Chengdu Medical College
Collaborator
