The First Affiliated Hospital of Xinjiang Medical University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Complete biochemical cure of PA
研究概览
简要总结
The aim of this study was to compare the efficacy and safety of adrenalectomy and superselective adrenal artery embolization in a prospective, multicenter, randomized controlled study. To provide a new interventional alternative therapy for primary aldosteronism.
详细描述
Primary hyperaldosteronism is caused by excessive aldosterone secretion caused by adrenal cortex disease, which leads to increased sodium and potassium discharge, increased fluid volume and inhibition of renin-angiotensin-aldosterone system. It is one of the common causes of secondary hypertension as clinical symptoms with hypertension, hypokalemia, hyperaldosterone and low renin. It accounts for 5% to 13% of people with hypertension. In addition to the impact of hypertension itself on the body, the endocrine hormone disorder and electrolyte imbalance associated with PA may also become independent risk factors for cardiovascular and cerebrovascular events, and the risk of stroke, atrial fibrillation and myocardial infarction is significantly higher than that of essential hypertension, so early detection and reasonable treatment are crucial. PA can be divided into 6 types according to the etiology, of which the most common is idiopathic aldosteronism (IHA) and aldosteronoma, accounting for 60% and 30% respectively, unilateral adrenal hyperplasia followed, the other subtypes are less common. Previous guidelines have recommended surgery and drug intervention as the main measures for the treatment of PA, while unilateral PA is preferred by surgery and laparoscopic adrenalectomy. However, surgical treatment also has many limitations: First, not all patients with surgical indications have the opportunity to undergo adrenal resection. Surgical treatment is not suitable for patients with difficult laparoscopic operation, such as obesity, serious abdominal adhesion due to previous surgical history, and high-risk surgery, such as cardiovascular and cerebrovascular diseases and emphysema. In addition, adrenal resection may lead to adrenal dysfunction, serious infection, retroperitoneal hematoma and many other adverse reactions. The efficacy and safety of superselective adrenal artery embolization as a new alternative therapy for PA intervention have been proved. The aim of this study was to compare the efficacy of adrenectomy and superselective adrenal artery embolization according to international PASO evaluation criteria, and to conduct a prospective, multicenter, randomized controlled study in Xinjiang to explore the potential of SAAE as a treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society
- •Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria
- •Patients and their family members signed informed consent and agreed to participate in the study
排除标准
- •A history of severe hypersensitivity to contrast media
- •Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc
- •Renal insufficiency (serum creatinine > 176mmol/L or estimated glomerular filtration rate < min.1.73m2)
- •Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension
- •Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome)
- •Stroke, myocardial infarction and stent implantation occurred in the past 3 months
- •Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc
- •Participated in other clinical trials within the past 3 months
- •Pregnant, breastfeeding, or planning a pregnancy
- •Identify patients with alcohol allergy
结局指标
主要结局
Complete biochemical cure of PA
时间窗: 6 months post intervention
Complete biochemical cure of PA, defined (whilst off medications that might alter serum potassium or the RAS) by both: Normalisation of serum potassium, and Normalisation of ARR, or Elevated ARR and i). Baseline PAC \<190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
Complete clinical cure of PA
时间窗: 6 months post intervention
Complete clinical cure of PA, defined as normotension without antihypertensive medication
次要结局
- Change of liver enzymes(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of kidney function(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of fasting blood glucose(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of 24-h 24-h urine creatinine(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of the number of antihypertensive medications(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Adverse events(Reported throughout the study period. Approximately 2 years)
- Readmission rate(Reported throughout the study period. Approximately 2 years)
- Change of plasma aldosterone(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of plasma cortisol(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of plasma renin measured(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Changes in ambulatory blood pressure and baseline blood pressure(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of blood electrolytes (K+, Na +)(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of lipids profiles(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of 24-h urine microalbumin(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
研究者
Xiang Xie
Head of Hypertension Department, Clinical Professor
Xinjiang Medical University