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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperaldosteronism; Idiopathic Hyperaldosteronism
• Intervention / Treatment: Procedure: Superselective Adrenal Arterial Embolization; Drug: Spironolactone

Detailed Description

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
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Dong, MD; Phone Number: 86-010-88322387; Email: donghui666@sina.com
• Study Contact Backup: Name: Xiongjing Jiang, MD; Phone Number: 86-010-88322387; Email: jxj103@hotmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Xiongjing Jiang, MD; Phone Number: 86-010-88322387; Email: jxj103@hotmail.com
      • Sub-Investigator: Hui Dong, MD
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • Second Affiliated Hospital of Nanchang University
      • Contact: Yifei Dong, MD，PhD; Phone Number: 0791-87357354; Email: yf_dong66@126.com
  • Sichuan
    • Chengdu, Sichuan, China, 610500
      • Recruiting
      • The First Affiliated Hospital of Chengdu Medical College
      • Contact: Peijian Wang, MD; Phone Number: 86-18980718263; Email: wpjmed@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superselective Adrenal Arterial Embolization; Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization.	Procedure: 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.
Active Comparator: Spironolactone; Patients in this group will receive oral spironolactone.	Drug: Spironolactone; Patients will be treated with spironolactone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	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	3,6 months after randomization
Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline	Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline	3, 6 months after randomization
Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline	Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline	3, 6 months after randomization

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Collaborators: Second Affiliated Hospital of Nanchang University; First Affiliated Hospital of Chengdu Medical College
• Investigators: Principal Investigator: Xiongjing Jiang, MD, Fuwai Hospital, National Center for Cardiovascular Disease

Publications and helpful links

General Publications

• Dong H, Zou Y, He J, Deng Y, Chen Y, Song L, Xu B, Gao R, Jiang X. Superselective adrenal arterial embolization for idiopathic hyperaldosteronism: 12-month results from a proof-of-principle trial. Catheter Cardiovasc Interv. 2021 May 1;97 Suppl 2:976-981. doi: 10.1002/ccd.29554. Epub 2021 Feb 19.
• Zhao Z, Liu X, Zhang H, Li Q, He H, Yan Z, Sun F, Li Y, Zhou X, Bu X, Wu H, Shen R, Zheng H, Yang G, Zhu Z; Chongqing Endocrine Hypertension Collaborative Team. Catheter-Based Adrenal Ablation Remits Primary Aldosteronism: A Randomized Medication-Controlled Trial. Circulation. 2021 Aug 17;144(7):580-582. doi: 10.1161/CIRCULATIONAHA.121.054318. Epub 2021 Aug 16. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hypertension; Spironolactone; Hyperaldosteronism; Superselective adrenal arterial embolization; Mineralocorticoid receptor antagonists(
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hypertension; Hyperaldosteronism; Organic Chemicals; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Lactones; Pregnenes; Spironolactone
• Other Study ID Numbers: 2022-1714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No