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

Chinese Academy of Medical Sciences, Fuwai Hospital172 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

172

Conditions

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (3)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

RECRUITING

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: 3, 6 months after randomization

Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline

Time frame: 3, 6 months after randomization

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts