Adrenal Artery Ablation Treats Primary Aldosteronism With Resistant Hypertension (AAA-RHT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change of office systolic blood ptressure
研究概览
简要总结
Primary aldosteronism(PA) is the most common endocrine cause of resistant hypertension. Surgery and medicine are the main treatment for PA by the current guidelines. However,only a small part of patients with PA meet the surgical criteria, and most of them have to take spironolactone or other antihypertensive drugs for long time. On the other side, long-term inhibition of aldosterone receptor may cause hyperkalemia, male breast hyperplasia and other adverse reactions. Moreover, hyperaldosterone is still not corrected by spironolactone, which cause extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, the precise diagnosis and treatment of PA is possible. Selective adrenal artery ablation (AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promissing that primary aldosteronism with resistant hypertension could be relieved by adrenal artery ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age between 30-65 years old.
- •Primary aldosteronism with resistant hypertension.
- •Informed consent signed and agreed to participate in this trial.
排除标准
- •Secodary hyertension due to other causes.
- •History of depression,schizophrenia or vascular dementia .
- •History of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
- •Hypohepatia (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
- •Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- •Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- •Fertile woman without contraceptives.
- •Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the anti-hypertensive drugs.
- •Allergic to or have contraindication to the contrast agents and alcohol.
结局指标
主要结局
Change of office systolic blood ptressure
时间窗: 24 weeks
Change of office systolic blood pressure compared with baseline after 24 weeks.
次要结局
- Change of office dystolic blood pressure(24 weeks)
- Change of home systolic blood pressure(24 weeks)
- Change of 24-h average diastolic blood pressure(24 weeks)
- Change of plasma renin levels(24 weeks)
- Change of serum creatinine(24 weeks)
- Change of home diastolic blood pressure(24 weeks)
- Change of 24-h average systolic blood pressure(24 weeks)
- Change of DDD of anti-hypertensive regimen(24 weeks)
- Change of blood electrolytes(24 weeks)
- Change of plasma adrenal hormones(24 weeks)
研究者
Zhiming Zhu
Study Director
Third Military Medical University