An interventional study of Superselective Adrenal Arterial Embolization and Spironolactone in Idiopathic Hyperaldosteronism and Hyperaldosteronism, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 3 sites in China. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Treatment
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.
Idiopathic hyperaldosteronism (IHA), characterized by bilateral adrenal hyperplasia, constitutes approximately 65% of primary hyperaldosteronism cases. While Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone are the gold-standard medical therapy, their long-term use is frequently hampered by dose-dependent side effects, including gynecomastia, electrolyte imbalances, and renal insufficiency, leading to poor patient compliance.This study investigates Superselective Adrenal Artery Embolization (SAAE) as a minimally invasive interventional alternative. Unlike total adrenalectomy, SAAE targets specific terminal branches of the adrenal arteries to reduce aldosterone overproduction while preserving sufficient cortical function. Despite its clinical application over the last decade, high-quality comparative data between SAAE and pharmacological MRA therapy remain scarce.The primary objective of this research is to evaluate the safety and clinical efficacy of SAAE versus MRA through a randomized controlled trial.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 172 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization.
Procedure: Superselective Adrenal Arterial Embolization
Patients in this group will receive oral spironolactone.
Drug: Spironolactone
Patients 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.
Patients 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.
Time frame: 6 months after randomization
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.
Time frame: 6 months after randomization
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
Time frame: 1, 3, 6 months after randomization
change of antihypertensive medication burden at 1, 3, 6 months compared with baseline
change of antihypertensive medication burden at 6 months compared with baseline
Time frame: 1, 3, 6 months after randomization
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.
Time frame: 6 months after randomization
Change of Serum potassium at 3, 6 months after randomization, compared with baseline
Change of Serum potassium at 3, 6 months compared with baseline
Time frame: 3,6 months after randomization
Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline
Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline
Time frame: 3, 6 months after randomization
Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline
Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline
Time frame: 3, 6 months after randomization
Plan to share: No
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