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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Hyperaldosteronism; Idiopathic Hyperaldosteronism

Treatments: Drug: Spironolactone; Procedure: Superselective Adrenal Arterial Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT07328230

2022-1714

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 172 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged from 15 to 60 with no limits in sex;
2. Patients are diagnosed with primary aldosteronism according to the criteria of the 2016 Endocrine Society guidelines;
3. Sub-typing diagnosis confirmed idiopathic hyperaldosteronism;
4. Patients or their legal representatives have to sign written informed consent approved by the ethics committee.

Exclusion criteria

1. Unilateral adrenal hyperplasia;
2. 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；
3. Hemorrhagic or ischemic stroke, endovascular stent implantation and myocardial infarction within the previous 3 months;
4. Severe contrast agent allergy;
5. Women who are pregnant or planning to become pregnant;
6. Patients with other serious organic diseases cannot tolerate SAAE treatment;
7. Other forms of secondary hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

Superselective Adrenal Arterial Embolization

Experimental group

Description:

Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization.

Treatment:

Procedure: Superselective Adrenal Arterial Embolization

Spironolactone

Active Comparator group

Description:

Patients in this group will receive oral spironolactone.

Treatment:

Drug: Spironolactone