The Effect of Selective Adrenal Artery Embolism on Vascular Endothelial Function in Patients With Primary Aldosteronism Based on Brachial Artery Flow-mediated Relaxation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- endothelial function
研究概览
简要总结
The study aims to assess the effect of superselective adrenal arterial embolization on vascular endothelial function in patients with primary aldosteronism based on brachial artery flow-mediated relaxation
详细描述
After being informed about the study and potential risks,all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry.At week 0,patients who meet the eligibility requirements will be divided into Superselective adrenal arterial embolization group or spironolactone therapy group,according to the patient's surgical indications and wishes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Aged 18-75 years, males and females;
- •(2)Blood pressure ≥ 140/90 mmHg on at least three non-same-day office visits without antihypertensive medication or 24-hour ambulatory blood pressure averaging >130/80 mmHg throughout the day or averaging >135/85 mmHg during the day;
- •(3)Primary aldosteronism was diagnosed in accordance with the 2016 international society of Endocrinology clinical guidelines after strict drug elution;
- •(4)Contraindications to spironolactone-free administration;
- •(5)No surgical intention or surgical contraindications, and willing to accept drug treatment or percutaneous superselective adrenal artery embolization;
- •(6)The anatomy of adrenal arteriography is suitable for selective adrenal artery embolization.
排除标准
- •(1)Secondary hypertension of other causes;
- •(2)Pregnant women or those who have a fertility plan in the next year;
- •(3)Glomerular filtration rate EGFR < 45 ml/min/1.73m^2;
- •(4)History of severe contrast allergy;
- •(5)Hyperkalemia;
- •(6)Patients with other serious organic diseases or life expectancy < 12 months can not tolerate the treatment of super selective adrenal artery embolizatio;
- •(7)The diameter of adrenal space occupying lesions was more than 2 cm;
- •(8)A history of myocardial infarction, syncope, cerebral hemorrhage or cerebral infarction within 3 months before the informed consent;
- •(9)The results of this study will be affected during the period when patients are enrolled or will participate in other clinical studies.
研究组 & 干预措施
SAAE group
Subjects received super selective adrenal artery embolization treatment
干预措施: Super selective adrenal artery embolization (Procedure)
Spironolactone group
Subjects received spironolactone treatment
干预措施: Spironolactone (Drug)
结局指标
主要结局
endothelial function
时间窗: 12 months after SAAE
Brachial artery endothelial function measured by flow-mediated dilation(FMD)
次要结局
- PAC(12 months after SAAE)
- PRA(12 months after SAAE)
- ARR(12 months after SAAE)
- Serum potassium(12 months after SAAE)
- serum creatinine(12 months after SAAE)