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
- 500
- 试验地点
- 1
- 主要终点
- Complete clinical cure of PA
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primary aldosteronism, to provide new evidence plan for the diagnosis and treatment of primary aldosteronism, and to promote the development of adrenal artery embolization as a new treatment for primary aldosteronism.
详细描述
As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some people. Adrenal vein blood collection is a method to identify the types of primary hyperaldosteronism by comparing the ratio of aldosterone in venous blood by selective catheterization into adrenal vein. Superselective adrenal artery embolization is a catheter-based percutaneous cavitary procedure in which ethanol is selectively injected into the adrenal artery to ablate part of the adrenal gland. Recently, it has been used as an alternative therapy for patients with unilateral aldosterone-producing adenomas as well as idiopathic hyperaldosteronism without obvious adenomas. This is 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 years old;
- •Primary hyperaldosteronism was diagnosed in strict accordance with the 2016 International Endocrine Society clinical guidelines;
- •Refusal of medication due to adverse reactions, refusal of adrenal resection due to surgical risk, or persistent hyperaldosteronism and cortical insufficiency after adrenal resection;
- •The patients and their families were introduced in detail to all the current treatment methods for primary aldosteronism, and the adrenal artery embolization was voluntarily accepted;
排除标准
- •A history of severe hypersensitivity to contrast media;
- •There are serious complications of liver disease, such as thrombocytopenia, esophageal variceal 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, estrogens, herbs containing glycyrrhizin), pregnancy hypertension and other secondary hypertension;
- •Hereditary diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesemia (Gitelman syndrome);
- •Cerebral apoplexy, myocardial infarction and stent implantation occurred in the past 3 months;
- •Serious other basic, such as heart dysfunction (grade IV), acute infection, autoimmune diseases, various malignant tumors and so on;
- •Participated in other clinical trials within the past 3 months;
- •Individual pregnancy, nursing or planning pregnancy;
结局指标
主要结局
Complete clinical cure of PA
时间窗: 6 months post intervention
Complete clinical cure of PA, defined as normotension without antihypertensive medication These criteria have been defined in the international consensus PASO statement8, which has become the established yardstick by which PA cure is judged. In this, normotension is defined, in accordance with the European Society of Hypertension guidelines22, as \<140/80 in the office, \<135/85 at home or daytime ambulatory monitoring and \<130/80 for 24h ambulatory blood pressure monitoring (24hABPM).
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: 1. Normalisation of serum potassium, and 2. Normalisation of ARR, or 3. Elevated ARR and i). Baseline PAC \<190pmol/L, or ii). Normal confirmatory test (as defined in the inclusion criteria)
次要结局
- 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 the number of antihypertensive medications(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
- Change of plasma aldosterone(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 24-h urine creatinine(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)
- Change of plasma renin measured(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)
- Readmission rate(Reported throughout the study period. Approximately 2 years)
- Change of blood electrolytes (K+, Na +)(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 liver enzymes(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 urine microalbumin(1 day, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months)
研究者
Xiang Xie
Xiangxie, MD,Professor, The First Affiliated Hospital Of XinJiang Medicial University
Xinjiang Medical University