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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Препарат Spironolactone
  Patients will be treated with spironolactone.

Первичные конечные точки

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

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

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

Публикации

• 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

Идентификаторы

NCT: NCT07328230 · 2022-1714

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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