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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-60
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Superselective Adrenal Arterial Embolization
  • Spironolactone

Treatment groups

172 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor

Second Affiliated Hospital of Nanchang University

Collaborator

First Affiliated Hospital of Chengdu Medical College

Collaborator