Adrenal Artery Ablation for Primary Aldosteronism：A Randomized, Parallel, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Adrenal Artery Ablation（AAA）in the Treatment of Primary Aldosteronism
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
Primary aldosteronism (PA) is one of the most common causes of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.
The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.
Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.
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
- •Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels ≥15 ng / dl, and confirmed by saline injection test or captopril inhibition test.
- •Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS).
- •The patients were diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision.
- •Signed informed consent and agreed to participate in this study.
排除标准
- •Aldosterone cancer.
- •Hyperkalemia.
- •Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome.
- •Secondary hypertension except the primary aldosteronism.
- •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.
- •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
Intevention
Patients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg.
干预措施: Endovascular chemical Ablation of Adrenal Gland (Procedure)
Intevention
Patients in this group will be treated with endovascular chemical ablation of adrenal glandp by endovascular injection of dehydrated alcohol. Sequenced antihypertensvie drugs with titrated dosage(amlodipine 5-10 mg/d ; terazosin 2-6mg/d) will be prescribed if home blood pressure (HBP) exceeds ≥160/100 mmHg.
干预措施: Sequenced antihypertensvie drugs with titrated dosage (Drug)
Control
Patients in this group will be treated only with sequenced antihypertensvie drugs with titrated dosage(amlodipine 5mg/d→plus spironolactone 20 mg/d→plus spironolactone 40 mg/d→plus spironolactone 60 mg/d→→plus amlodipine 10 mg/ d →plus terazosin 2-6mg / d) if home blood pressure (HBP) exceeds ≥160/100 mmHg.
干预措施: Sequenced antihypertensvie drugs with titrated dosage (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 compared with the baseline at the end of the study (24 weeks) between the intervention and control group is to be analysed.
次要结局
- Change of cardiac parameters assessed by echocardiography (IVSd、IVSs、LVPWd, LVPWs, LVEDD, LVEF, LVM) measured at baseline and the end of the trial(24 weeks)
- Change of blood electrolytes（serum potassium and natrium in mmol/L）measured at baseline and the end of the trial(24 weeks)
- Change of plasma renin measured at baseline and the end of the trial(24 weeks)
- Change of anti-hypertensive regimen assessed at baseline and the end of the trial(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 fasting blood glucose and lipids profiles measured at baseline and the end of the trial(24 weeks)
- Change of carotid intima-media thickness assessed by carotid ultrasound at baseline and the end of the trial(24 weeks)
- Change of 24-h average systolic blood pressure measured at the end of the trial compared with the baseline(24 weeks)
- Change of liver enzymes measured at baseline and the end of the trial(24 weeks)
- Change of sex hormones measured at baseline and the end of the trial(24 weeks)
- Change of 24-h urine microalbumin, microalbumin/creatinine ratio measured at baseline and the end of the trial(24 weeks)
- Change of plasma aldosterone and 24-h urine aldosterone 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 kidney function 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