Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Uncontrolled Hypertension: A Randomized, Parallel, Active-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
研究概览
简要总结
The activation of the renin-angiotensin-aldosterone system (RAAS) plays a key role in uncontrolled hypertension or resistant hypertension. Surgery and and medicine are the main treatment for primary aldosteronism(PA) by the current guidelines. However, only a small part of patients with PA meet the surgical criteria, and most of patients with uncontrolled hypertension and activation of RAAS 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 causes extensive cerebrovascular damages even though blood pressure and blood potassium had been normalized.
With the development of adrenal vein sampling and adrenal ablation, selective arterial ablation of adrenal gland(AAA) was observed with significant decrease of blood aldosterone and blood pressure in patients with PA, which made it promising that uncontrolled hypertension could be relieved by selective AAA.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 30-60 years old.
- •Patients with poorly controlled hypertension (office blood pressure ≥130/80 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 2 weeks
- •Positional blood aldosterone ≥100pg/ml.
- •Informed consent signed and agreed to participate in this trial.
排除标准
- •Hyperkalemia or hypokalemia.
- •Secondary hypertension.
- •History of depression, schizophrenia or vascular dementia.
- •Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- •Adrenergic insufficiency.
- •Heart failure with NYHA grade Ⅱ-Ⅳ grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events.
- •Acute infections, tumors and severe arrhythmias, psychiatric disorders,
- •drugs or alcohol addicts.
- •Liver dysfunction or the following history of liver disease: AST or ALT 3 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history.
- •Fertile woman without contraceptives.
- •Coagulation dysfunction.
- •Pregnant women or lactating women.
- •Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial.
- •Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug.
- •Allergy or any contraindications for the study drugs, contrast agents and alcohol.
- •Refused to sign informed consent
研究组 & 干预措施
Intervention
Selective endovascular chemical ablation of adrenal gland after adrenal angiography.
干预措施: Selective endovascular chemical ablation of adrenal gland (Procedure)
Intervention
Selective endovascular chemical ablation of adrenal gland after adrenal angiography.
干预措施: Traditional triple antihypertensive treatment (Drug)
Control
No intervention, but treated with standard antihypertensive drugs
干预措施: Traditional triple antihypertensive treatment (Drug)
结局指标
主要结局
Change of 24-h average systolic blood pressure measured at baseline and the end of the trial
时间窗: 24 weeks
Difference in the change of 24-h average systolic blood pressure between the intervention and control group is to be analysed.
次要结局
- Change of plasma renin measured at baseline and the end of the trial(24 weeks)
- Change of home systolic and diastolic pressure measured at baseline and the end of the trial(24 weeks)
- Change of anti-hypertensive regimen measured at baseline and the end of the trial(24 weeks)
- Change of blood electrolytes measured at baseline and the end of the trial(24 weeks)
- Change of plasma and urine adrenal hormones measured at baseline and the end of the trial(24 weeks)
- Change of 24-h average systolic blood pressure compared with the baseline(24 weeks)
- Change of 24-h average diastolic blood pressure, daytime mean systolic blood pressure, daytime mean diastolic blood pressure, and nighttime average systolic and diastolic blood pressure measured at baseline and the end of the trial(24 weeks)
- Change of office systolic and diastolic pressure measured at baseline and the end of the trial(24 weeks)
- Change of liver enzymes measured at baseline and the end of the trial(24 weeks)
- Change of fasting blood glucose measured at baseline and the end of the trial(24 weeks)
- Change of kidney function measured at baseline and the end of the trial(24 weeks)
- Change of lipids profiles measured at baseline and the end of the trial(24 weeks)
研究者
Zhiming Zhu
Director of the Department of Hypertension & Endocrinology, Daping Hospital
Third Military Medical University