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

NCT07328230 · tracked via the Priya Life Science China tracker

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Phase

Not applicable

Started

2022-08-01

Last updated

2026-01-09

Condition(s) studied

Idiopathic HyperaldosteronismHyperaldosteronism

Investigational drug(s) / intervention(s)

Superselective Adrenal Arterial EmbolizationSpironolactone →

Superselective 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.

Spironolactone: Patients will be treated with spironolactone.

Study 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

Sex

ALL

Min age

15 Years

Max age

60 Years

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.

Primary outcome measure(s)

Change of 24-h mean systolic blood pressure at 6 months compared with baseline. — 6 months after randomization
change of 24-h mean systolic blood pressure at 6 months compared with baseline.

Trial sites (3)

Facility	City	Region	Status
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing Municipality	Recruiting
Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	Recruiting
The First Affiliated Hospital of Chengdu Medical College	Chengdu	Sichuan	Recruiting

On this site

📄 Aldactone (spironolactone) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07328230 on ClinicalTrials.gov ↗ ← All trials in China