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临床试验/NCT06282107
NCT06282107尚未招募不适用

Effectiveness and Safety of Bilateral Superselective Adrenal Arterial Embolization (BiSAAE) for Resistant Hypertension

First Affiliated Hospital of Chengdu Medical College0 个研究点目标入组 72 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
主要终点
Change of 24-h average systolic blood pressure

研究概览

简要总结

Hypertension is a common problem, affecting >1.1 billion people worldwide. Unfortunately, fewer than one in five treated patients with hypertension have their blood pressure (BP) under control. The increasing number of people with uncontrolled BP despite the use of three or more antihypertensive agents at optimal or maximally tolerated doses, with one of those agents preferably being a diuretic has been described as the resistant hypertension (RH). Achieving BP control is essential because patients with hypertension who have uncontrolled BP have significantly higher rates of all-cause, cardiovascular, heart disease and cerebrovascular disease mortality compared to normotensive individuals, whereas mortality risk in patients with well-controlled BP does not differ from that in normotensive individuals. There are a number of potential factors that contribute to the suboptimal control of hypertension, including medication non-adherence and prescribing inertia. This highlights the limitations of purely pharmacological approaches for the effective management of hypertension. In fact, the activation of the renin-angiotensin-aldosterone system (RAAS) and sympatho-adrenomedullary system play a pathogenic role in triggering and sustaining RH. Superselective adrenal arterial embolization (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. Over the last decade, unilateral SAAE has emerged as a potential treatment option for patients with primary aldosteronism. Whether this approach can be extrapolated to patients with RH is unclear. We thus set out to perform a randomized trial to compare the safety and efficacy of bilateral SAAE with antihypertensive medications in treating RH.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, aged between 30-65 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

结局指标

主要结局

Change of 24-h average systolic blood pressure

时间窗: 3-month

Difference in the change of 24-h average systolic blood pressure between the intervention and control group

次要结局

  • 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(12-month)
  • Change of 24-h urine microalbumin(3-month)
  • Change of home systolic and diastolic pressure(3-month)
  • Change of echocardiography parameters (LVEF)(3-month)
  • Difference in the change of office systolic and diastolic pressure between the intervention and control group(3-month)
  • Difference in the change of blood electrolytes (K+, Na + in mmol/L) between the intervention and control group(3-month)
  • Change of plasma aldosterone(3-month)
  • Change of liver enzymes(3-month)
  • Change of fasting blood glucose(12-month)
  • Change of echocardiography parameters (IVSd、IVSs、LVPWd, LVPWs, LVEDD)(3-month)
  • Change of plasma cortisol(3-month)
  • Change of kidney function(3-month)
  • Change of lipids profiles(3-month)
  • Change of 24-h urine creatinine(3-month)
  • Change of plasma renin measured(3-month)
  • Change of carotid intima-media thickness(3-month)

研究者

发起方
First Affiliated Hospital of Chengdu Medical College
申办方类型
Other
责任方
Sponsor

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