A Randomized Controlled Trial Comparing Superselective Adrenal Arterial Embolization and Oral Spironolactone for Idiopathic Hyperaldosteronism Treatment

What this Trial Is About

Idiopathic hyperaldosteronism (IHA) is a common cause of primary hyperaldosteronism, representing about 65% of cases. This condition involves overproduction of aldosterone due to bilateral adrenal hyperplasia. Researchers are evaluating the safety and effectiveness of superselective adrenal artery embolization (SAAE), a minimally invasive procedure, compared to the standard oral medication spironolactone, a mineralocorticoid receptor antagonist (MRA), to see if SAAE could be a feasible treatment option for IHA. The study involves two groups: one group will receive SAAE, where a catheter is guided into the adrenal arteries to inject ethanol and reduce aldosterone production while preserving adrenal function; the other group will take spironolactone orally. The treatments are compared over a period of six months following randomization. SAAE is performed percutaneously under imaging guidance, and spironolactone is administered according to standard doses. Participants will be monitored regularly with blood pressure measurements at 1, 3, and 6 months, including 24-hour mean systolic and diastolic blood pressure and office blood pressure. Researchers will also track changes in medication use, blood potassium levels, hormone concentrations, kidney function, and clinical events. The primary outcome is the change in 24-hour mean systolic blood pressure at 6 months. The study lasts six months after treatment, with ongoing safety and efficacy assessments.

Superselective Adrenal Arterial Embolization Versus Oral Spironolactone for Treatment of Idiopathic Hyperaldosteronism