A Prospective Randomized Controlled Trial for Treatment of Idiopathic Hyperaldosteronism: Superselective Adrenal Arterial Embolization Versus Oral Spironolactone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 3
- 主要终点
- Change of 24-h mean systolic blood pressure at 6 months compared with baseline.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Superselective Adrenal Arterial Embolization
Patients in the experimental group will undergo percutaneous superselective adrenal arterial embolization.
干预措施: Superselective Adrenal Arterial Embolization (Procedure)
Spironolactone
Patients in this group will receive oral spironolactone.
干预措施: Spironolactone (Drug)
结局指标
主要结局
Change of 24-h mean systolic blood pressure at 6 months compared with baseline.
时间窗: 6 months after randomization
change of 24-h mean systolic blood pressure at 6 months compared with baseline.
次要结局
- 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)
- 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(3, 6 months after randomization)
研究者
Xiongjing Jiang
professor
Chinese Academy of Medical Sciences, Fuwai Hospital