RecruitingNot ApplicableNCT07328230

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

A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Enrollment

172 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Idiopathic Hyperaldosteronism Hyperaldosteronism

Summary

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.

Eligibility

Min Age: 15 YearsMax Age: 60 Years

Inclusion Criteria4

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.

Exclusion Criteria7

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;
Women who are pregnant or planning to become pregnant;
Patients with other serious organic diseases cannot tolerate SAAE treatment;
Other forms of secondary hypertension.

Interventions

PROCEDURESuperselective Adrenal Arterial Embolization

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.

DRUGSpironolactone

Patients will be treated with spironolactone.