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

NCT ID: NCT07328230

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Idiopathic Hyperaldosteronism; Hyperaldosteronism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Superselective Adrenal Arterial Embolization

Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization.

Group Type: EXPERIMENTAL

Superselective Adrenal Arterial Embolization

Intervention Type: PROCEDURE

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 in this group will receive oral spironolactone.

Group Type: ACTIVE_COMPARATOR

Spironolactone

Intervention Type: DRUG

Patients will be treated with spironolactone.

Interventions

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.

Intervention Type: PROCEDURE

Spironolactone

Patients will be treated with spironolactone.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chengdu Medical College

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiongjing Jiang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiongjing Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, National Center for Cardiovascular Disease

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiongjing Jiang, MD

Role: CONTACT

jxj103@hotmail.com

86-010-88322387

Hui Dong, MD

Role: CONTACT

donghui666@sina.com

86-010-88322387

Facility Contacts

Xiongjing Jiang, MD

Role: primary

jxj103@hotmail.com

86-010-88322387

Yifei Dong, MD，PhD

Role: primary

yf_dong66@126.com

0791-87357354

Peijian Wang, MD

Role: primary

wpjmed@aliyun.com

86-18980718263

References

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.

Reference Type: RESULT

PMID: 33605538 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34398686 (View on PubMed)

Other Identifiers

2022-1714

Identifier Type: -

Identifier Source: org_study_id