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

NCT07328230 | Recruiting

• 1 other identifier: 2022-1714
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

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.

Conditions

Hyperaldosteronism; Idiopathic Hyperaldosteronism

Keywords

Superselective adrenal arterial embolization; Spironolactone; Hyperaldosteronism; Hypertension; Mineralocorticoid receptor antagonists(

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  1, 3, 6 months after randomization

• change of antihypertensive medication burden at 1, 3, 6 months compared with baseline

  1, 3, 6 months after randomization

• Incidence of clinical events

  6 months after randomization

• Change of Serum potassium at 3, 6 months after randomization, compared with baseline

  3,6 months after randomization

Study Arms (2)

Superselective Adrenal Arterial Embolization

EXPERIMENTAL

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

Procedure: Superselective Adrenal Arterial Embolization

Spironolactone

ACTIVE COMPARATOR

Patients in this group will receive oral spironolactone.

Drug: Spironolactone

Interventions

Superselective Adrenal Arterial Embolization 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.

Superselective Adrenal Arterial Embolization

Spironolactone DRUG

Patients will be treated with spironolactone.

Spironolactone

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Women who are pregnant or planning to become pregnant;
• Patients with other serious organic diseases cannot tolerate SAAE treatment;
• Other forms of secondary hypertension.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead
• Second Affiliated Hospital of Nanchang University: collaborator
• First Affiliated Hospital of Chengdu Medical College: collaborator

Study Sites (3)

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

Beijing, Beijing Municipality, 100037, China

RECRUITING

Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610500, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33605538 RESULT

• 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.

  PMID: 34398686 RESULT

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Xiongjing Jiang, MD

  Fuwai Hospital, National Center for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiongjing Jiang, MD

CONTACT

86-010-88322387; jxj103@hotmail.com

Hui Dong, MD

CONTACT

86-010-88322387; donghui666@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 9, 2026
• Study Start: August 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)