Effectiveness and Safety of Superselective Adrenal Arterial Embolization (SAAE) for Resistant Hypertension: A Randomized, Parallel, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- Change of 24-h average systolic blood pressure
研究概览
简要总结
Resistant hypertension (RH) is usually defined as blood pressure (BP) that remains above guideline-specified targets despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic. It is not uncommon, being identified in 10 to 30% of hypertensive patients and it is known to be a risk factor for cardiovascular (CV) events, including stroke, myocardial infarction (MI), heart failure (HF), and CV mortality, as well as adverse renal events,including chronic kidney disease (CKD) and end-stage kidney disease (ESKD). The activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system can play a pathogenic role in triggering and sustaining RH. SAAE is a catheter-based percutaneous transluminal procedure which selectively injects ethanol into adrenal artery to ablate part of the adrenal gland for suppression of excessive aldosterone and catecholamines. Therefore, SAAE is a minimally invasive procedure that might be used as an alternative strategy to antihypertensive drugs or reduce the intensity of antihypertensive drugs.
详细描述
Not Provided
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
- 18 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, aged between 18-65 years old.
- •Patients with resist hypertension (office systolic blood pressure ≥140 mmHg, and/or office diastolic blood pressure ≥90 mmHg, and/or 24-h average systolic blood pressure ≥130 mmHg) with rational lifestyle change and triple antihypertensive drugs (irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d) for at least 4 weeks.
- •Informed consent signed and agreed to participate in this trial.
排除标准
- •Secondary hypertension
- •Adrenergic insufficiency.
- •adrenocortical insufficiency
- •Renal failure eGFR<60 mL/min/1.73 m2
- •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.
- •History of depression, schizophrenia or vascular dementia.
- •Refused to sign informed consent
研究组 & 干预措施
Superselective adrenal arterial embolization
Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland
Interventions:
Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment
干预措施: SAAE (Procedure)
Superselective adrenal arterial embolization
Selectively injects ethanol into adrenal artery to ablate part of the adrenal gland
Interventions:
Procedure: superselective adrenal arterial embolization Drug: traditional triple antihypertensive treatment
干预措施: traditional triple antihypertensive treatment (Drug)
Traditional triple antihypertensive treatment
No intervention, but treated with traditional triple antihypertensive treatment
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
时间窗: 6-month
Difference in the change of 24-h average systolic blood pressure between the intervention and control group
次要结局
- Change of plasma cortisol(6-month)
- Change of plasma renin measured(6-month)
- Change of liver enzymes(6-month)
- Change of kidney function(6-month)
- Change of fasting blood glucose(6-month)
- Change of lipids profiles(6-month)
- Change of 24-h urine microalbumin(6-month)
- Change of 24-h 24-h urine creatinine(6-month)
- Change of echocardiography parameters (LVEF)(6-month)
- Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)(6-month)
- Change of carotid intima-media thickness(6-month)
- 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(6-month)
- Change of the number of antihypertensive medications(6-month)
- Change of home systolic and diastolic pressure(6-month)
- Change of office systolic and diastolic pressure(6-month)
- Change of blood electrolytes (K+, Na +)(6-month)
- Change of plasma aldosterone(6-month)