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

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

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for idiopathic hyperaldosteronism — a condition where both adrenal glands (small glands above your kidneys) produce too much of a hormone that raises blood pressure. The two approaches being compared are a minimally invasive procedure (targeted artery embolization to reduce hormone production) versus the standard medication spironolactone. **You may be eligible if...** - You are between 15 and 60 years old - You have been diagnosed with primary aldosteronism (excess aldosterone hormone causing high blood pressure) according to established guidelines - Testing has confirmed you have idiopathic hyperaldosteronism (both adrenal glands are overactive, not just one) **You may NOT be eligible if...** - Only one of your adrenal glands is overactive (unilateral hyperplasia) - Your kidney function is significantly reduced - You have had a stroke, heart stent, or heart attack in the past 3 months - You have a severe allergy to contrast dye used in imaging - You are pregnant or planning to become pregnant - You have another serious condition that prevents the embolization procedure - You have another form of secondary high blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(3)

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

Beijing, Beijing Municipality, China

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

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NCT07328230


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