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

Official title

A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone

Overview

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.

Interventions

• 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.
• Drug Spironolactone
  Patients will be treated with spironolactone.

Primary outcome measures

• Change of 24-h mean systolic blood pressure at 6 months compared with baseline. [Time frame: 6 months after randomization]

Secondary outcome measures (7)

• Change of 24-h mean diastolic blood pressure at 6 months compared with baseline. [Time frame: 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 [Time frame: 1, 3, 6 months after randomization]
• change of antihypertensive medication burden at 1, 3, 6 months compared with baseline [Time frame: 1, 3, 6 months after randomization]
• Incidence of clinical events [Time frame: 6 months after randomization]
• Change of Serum potassium at 3, 6 months after randomization, compared with baseline [Time frame: 3,6 months after randomization]
• Change of plasma aldostrone, renin, cortisol concentration at 3, 6 months compared with baseline [Time frame: 3, 6 months after randomization]
• Change of estimated glomerular filtration rate(eGFR) and at 3, 6 months compared with baseline [Time frame: 3, 6 months after randomization]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 3 centers

• Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sci — Beijing
• Second Affiliated Hospital of Nanchang University — Nanchang
• The First Affiliated Hospital of Chengdu Medical College — Chengdu

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. PMID 33605538
• 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

Identifiers

NCT: NCT07328230 · 2022-1714

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗